No.2, to organize and lead the discussion with respective department related with customer feedback.To implement and follow up Corrective Action Preventive Action (CAPA) system related with Customer Relationship Management (CRM) following global standardSupport in preparation of quality department monthly reportPrepare statement letter according to customer or organization requirementFill out customer questionnaire according to agreed timeline.Participate in the validation of special projects such as new machines, new materials, and so on (outside of routine validation).If necessary, discuss with customer (visit or telco) related with customer feedback and Acceptable Quality Level (AQL).To review batch record and release the finished good to be sent to customer according to established procedure.Participate in DMF renewalGive disposition of whether a batch can be released to be shipped to customer.
About us Your Contribution Own and control project scopes, schedules and budgets; manage risks/issues and communicate status to stakeholdersLead cross functional execution with Production, Quality, Maintenance, Supply Chain, EHS, and Global EngineeringManage CAPEX, PO releases, FAT/SAT planning, cost tracking/forecasting and accurals; deliver fiscal year plan on time and on budgetPrepare and maintain audit ready documentation aligned to US cGMPOperate in accordance with standard cleanroom conduct consistent with ISO 14644 practices and internal QMS and site Contamination Control StrategyOwn change controls (local and global)- initiaiton, risk assessment, execution plan, verification of effectivensss and closure Lead/support validation and qualification for equipment, products, processes, etc.Integrate into operations; plan trials and downtime, coordinate line readiness/tech transfer, create/update SOPs, define PM requirements and maintenance plans, ensure spares/training are in placeSupport quality investigationsDrive continuous improvement with Lean to improve OEE, scrap rates, uptime and cycle times Mentor/train Engineers and Technicians (no direct reports); structured troubleshooting/problem solving and Best Known Methods; develop quick-reference guides/checklist, where needed Promote safety and EHS and adhere to all Company policies, procedures and guidelines Your Profile Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent4+ years in regulated manfuacturing Project management and CAPEX executionSix Sigma Green/Black Belt and/or PMPValidation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls Working knowledge of cGMP, ISO 9001, ISO 15378Knowledge and experience in leading new equipment/NPI validationsLean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)Tools: SAP, MS Project, MS TEAMS, Solidworks and MinitabStrong skills in MS Office Ability to read, write and speak EnglishTeam player with upbeat approach Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial/Manufacturing, Pharmaceutical or Materials) or equivalent4+ years in regulated manfuacturing Project management and CAPEX executionSix Sigma Green/Black Belt and/or PMPValidation and QMS: URS, FMEA, VMP, IQ/OQ/PQ/PV; author/review protocols/reports, managing deviations/CAPA; change controls Working knowledge of cGMP, ISO 9001, ISO 15378Knowledge and experience in leading new equipment/NPI validationsLean/CI; 5S, Kaizen, DMAIC, root cause (5-why, fishbone)Tools: SAP, MS Project, MS TEAMS, Solidworks and MinitabStrong skills in MS Office Ability to read, write and speak EnglishTeam player with upbeat approach
About us Your Contribution Provide support to Production by visually inspecting sterilized glass vials throughout daily activities; identify and classify defectsPerform visual inspection and testing of incoming materials using statistical sampling techniques, precision measuring instrumentation and FT-IR to ensure conformancePerform laboratory tests including endotoxin, bioburden and sub visible particlePerform Environmental Monitoring in ISO level Clean Room including compressed air testingConduct inventory of laboratory supplies and communication needs for order placement(s)Collect WFI (Water For Injection) for testing using aseptic techniqueCommunicate non-conforming issues and interact effectively with proper contact(s)Demonstrate flexibility in providing coverage during instances of co-work vacation time and/or medical absence(s)Cross train in other areas and/or functions of the laboratory to support business needsComplete daily, weekly and monthly cleaning of applicable laboratory areasReview testing documents for completeness and accuracyMaintain all laboratory notebooks and equipment log booksWork on all assigned tasks, projects and daily tasksFollow all Company policies and proceduresParticipate in required trainings and meetings, when necessaryHelp promote and implement safety/EHS directives and maintain a clean and safe workspaceFollow cGMP and adhere to all ISO and safety guidelines and policies Your Profile High School Diploma or GED, requiredQuality Control and laboratory experience, preferredExperience working in a fast-paced manufacturing settingUnderstanding of cGMP and ISO, preferredBasic computer knowledge and skills including MS OfficeMulti-tasking abilitiesDetail oriented approach; ability to follow directions and instructionsPositive team approachEffective communication skillsAbility to read, write and speak English language Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact usYour Profile High School Diploma or GED, requiredQuality Control and laboratory experience, preferredExperience working in a fast-paced manufacturing settingUnderstanding of cGMP and ISO, preferredBasic computer knowledge and skills including MS OfficeMulti-tasking abilitiesDetail oriented approach; ability to follow directions and instructionsPositive team approachEffective communication skillsAbility to read, write and speak English language
Besuchen Sie uns auch gerne auf unserer Website: www.ecc-experts.info Project Quality Manager (m/w/d) Experten. Talente. Persönlichkeiten. Profitieren Sie bei Ihrer Jobsuche von unserer Expertise und einem starken Netzwerk attraktiver Unternehmen.
Project Quality Manager (m/w/d) Für unseren Kunden, einen der führenden Übertragungsnetzbetreiber in Europa, suchen wir Sie! Ihre Aufgaben Erstellung und Aktualisierung des Projekthandbuchs, der projektspezifischen Verfahrensanweisungen, QS-Checklisten, QM-Dokumentation und Sicherstellung deren Einhaltung bzw.
Für unseren Standort Dresden / Breslau suchen wir Sie zur Verstärkung unseres Teams in Vollzeit Project Manager Cyber Security (m/w/d) Das erwartet Sie: In dieser Rolle planen, koordinieren und steuern Sie sämtliche Cybersecurity-Aktivitäten innerhalb von automobilen Entwicklungsprojekten.
About us Your Contribution Possess knowledge and capabilities to execute Maintenance/Facilities Technician (all levels) roles and responsibilitiesMonitor daily work orders and employee activitiesCoordinate with various department stakeholders on Maintenance actionsHelp minimize machine downtimeLead, coach and train Maintenance TechniciansProcure parts, materials and resources to increase machine uptime; impart expertise and techniques to others within the departmentEstablish shift schedules to meet business needs; manage employee schedulesActively lead and participate in projects/events to drive improvementsFill in for the Maintenance Manager, as neededHelp with achieving department deliverables and initiatives Participate in the interviewing/hiring processHost meetings accordinglyEnsure clean and safe workspacesMaintain attendance within the payroll systemFollow cGMP and adhere to all ISO and safety guidelines and policies Your Profile High School Diploma or GED, required / Vocational school degree, preferredMinimum (3) years of maintenance/facilities experience in leading and directing the work of others in a fast-paced manufacturing settingStrong mechanical aptitudeUnderstanding of ISO and cGMPAbility to foster and follow directions and instructionsAbility to read, write and speak English languageMulti-tasking abilitiesDetail oriented approachUpbeat, team approachService orientedRobust communication skills and openness to learn/developWork a fixes 8-hour shift schedule Monday to Friday, but some weekend/night work, as neededUp to 5% travel, if needed to satisfy business demand Your Benefits Excellent healthcare benefits including medical, dental and visionShort and long term disability Tuition reimbursement Paid time offPet insurance Other supplemental benefits available upon election Please feel free to contact us You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future.
Further training and education; Free Parking; Medical, Dental and Vision coverage; Talent development; Team Events; paid vacation days, holidays and sick time Please feel free to contact us You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future. Do you want to be successful with us? Then, please send us your application: SCHOTT Glass (Malaysia) Sdn.
Talent development; Free Parking; Further training and education; Medical, Dental and Vision coverage; Multiple career opportunities; Team Events; paid vacation days, holidays and sick time Please feel free to contact us You can expect interesting tasks and challenging projects, as well as motivated and friendly teams in fields that influence our future. Do you want to be successful with us? Then, please send us your application: SCHOTT Glass (Malaysia) Sdn.
Ihr Aufgaben End-to-End Projektmanagement: Verantwortung für die Planung, Steuerung und erfolgreiche Umsetzung komplexer Kundenprojekte im Bereich der Antriebstechnik.Interdisziplinäre Leitung: Führung von Projektteams nach APQP-Standards (Advanced Product Quality Planning) sowie Definition technischer Arbeitspakete.Reporting & Controlling: Erstellung von Terminplänen (MS Project), Durchführung von Risikobewertungen (FMEA) und regelmäßiges Reporting an die Geschäftsführung.Schnittstellenmanagement: Enge Zusammenarbeit mit der Konstruktion (CAD/PLM), dem Vertrieb und der Fertigung zur Sicherstellung der Cost-, Quality- and Delivery-Ziele (CQD).Prozessoptimierung: Aktive Mitwirkung bei der Weiterentwicklung von Standards im Projektmanagement am Standort in der Region Eisenbach.
Register now and look forward to many interesting and suitable positions and projects. Coordinate activities within the transformation program across defined workstreams Refine program scope, timelines, and budget as required Prepare materials and documentation for steering committee meetings Maintain RAID logs, coordinate project related communication and escalations with stakeholders Prepare decision proposals and support the transparent execution of the program Ensure all program activities comply with regulatory requirements and quality standards (e.g., GMP, GAMP, ISO standards) Apply established methods and tools for quality assurance and project coordination (e.g., SAP, QMS, TrackWise, CAPA) Align with multiple stakeholders, including senior managers and subject matter experts, to ensure successful program delivery Knowledge in GMP Knowledge in GAMP Knowledge in SAP Knowledge in QMS Knowledge in TrackWise Knowledge in CAPA Possibility of extending the project Ihr Kontakt Ansprechpartner Daniel Grudentaler Referenznummer 865825/1 Kontakt aufnehmen E-Mail: daniel.grudentaler@hays.de Anstellungsart Freiberuflich für ein Projekt
Vollzeit / Teilzeit (mind. 35h/Woche) | Team Lead Project Management | Vor Ort mit Möglichkeit für mobiles Arbeiten Bist du ein erfahrener Projektmanager, der gerne über einzelne Projekte hinausblickt und ein gesamtes Portfolio aus strategischer Perspektive steuert?
Register now and look forward to many interesting and suitable positions and projects. Coordinate activities within the transformation program across defined workstreamsRefine program scope, timelines, and budget as requiredPrepare materials and documentation for steering committee meetings Maintain RAID logs, coordinate project related communication and escalations with stakeholders Prepare decision proposals and support the transparent execution of the program Ensure all program activities comply with regulatory requirements and quality standards (e.g., GMP, GAMP, ISO standards) Apply established methods and tools for quality assurance and project coordination (e.g., SAP, QMS, TrackWise, CAPA) Align with multiple stakeholders, including senior managers and subject matter experts, to ensure successful program delivery Knowledge in GMPKnowledge in GAMPKnowledge in SAPKnowledge in QMSKnowledge in TrackWiseKnowledge in CAPA Possibility of extending the project Ihr Kontakt Ansprechpartner Daniel Grudentaler Referenznummer 865825/1 Kontakt aufnehmen E-Mail: daniel.grudentaler@hays.de Anstellungsart Freiberuflich für ein Projekt
Willingness to travel: You are ready to travel and work flexibly on-site according to project requirements. Do you want to take an active role in changing wind energy infrastructure? Apply now and contribute directly to pioneering sustainable concrete & hybrid tower technology in Germany.
Willingness to travel: You are ready to travel and work flexibly on-site according to project requirements. Do you want to take an active role in changing wind energy infrastructure? Apply now and contribute directly to pioneering sustainable concrete & hybrid tower technology in Germany.
Kennziffer 4396 Einsatzort: Berlin-Marienfelde Bringen Sie Ihre Expertise im Risikomanagement in ein zukunftsweisendes Offshore-Großprojekt ein. Als Project Risk Manager (m/w/d) gestalten Sie aktiv die Risikostrategie eines hochkomplexen HVDC-Infrastrukturprojekts mit – und leisten einen entscheidenden Beitrag zur sicheren und effizienten Projektumsetzung.
EN ISO 13849, EN 60204)Ability to guide a team of electricians and manage the work of Electrical Designers.Excellent Knowledge of two or more CAD Software.Ability to do project management for middle to large industrial projects.Ability to teach and train lower level personal.Support in sales and writing quotations Additional information SAR Automation LP is an Equal Opportunity Employer.
We offer numerous internal seminars, training sessions, and certification courses, such as those in project management or digital transformation, as well as development programs for current and future leaders. Your onboarding program includes a company-wide event where you can establish a foundation for networking across the organization.
This is achieved through tailored training programs and relevant projects, enabling sustainable career progression, for example, from a project team member to a project manager.
We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge.
We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge.
Register now and look forward to many interesting and suitable positions and projects. Mein Arbeitgeber Fire Point Rocket Technology (FPRT) is a defense technology company at the intersection of advanced chemistry and modern rocket propulsion.
Register now and look forward to many interesting and suitable positions and projects. Mein Arbeitgeber Fire Point Rocket Technology (FPRT) is a defense technology company at the intersection of advanced chemistry and modern rocket propulsion.
Operates machine for customers’ factory acceptance test Tests customers’ materials and product for packaging; provide feedback to engineers and project management; suggest improvements to resolve technical issues Troubleshoots electrical and mechanical problems and notifies required personnel, makes necessary approved modifications and corrections during start-up and checkout and documents changes.
Operates machine for customers’ factory acceptance test Tests customers’ materials and product for packaging; provide feedback to engineers and project management; suggest improvements to resolve technical issues Troubleshoots electrical and mechanical problems and notifies required personnel, makes necessary approved modifications and corrections during start-up and checkout and documents changes.
Diese Herausforderungen übernehmen Sie: Independent concept and generation of the mechanical integration and Test procedures at satellite- and instrument level in one of our large space projects in compliance with functional requirements and cost plansAutonomous execution of mechanical integration and test activitiesDefinition of the MGSE in compliance with technical parameters and tost requirements, support the MGSE procurement considering the budget and schedule constraintsSupport of the Project and System Engineering Teams throughout all project phases with regard to mechanical AIT aspects, be prepared to interface with customers and subcontractorsInterface and harmonize with the teams of related disciplines like Optics, Electric, Work preparation and manufacturingPreparation and implementation of standard AIT boards such as TRR, PTR and TRB, participation in project reviewsImpact Assessment on problems and non-conformances with the proper documentation and pro-active seeking of support of other experts when necessaryTimely preparation and compilation of required AIT documents, such as AIT plans, procedures, and test reportsIn cooperation with Product Assurance: keeping log-sheet records, compilation of non-conformance and problem reports Ihr Profil: Diploma in mechanical engineering or similarPractical experience within satellite space projects, in Phase C/D, experience in mechanical integration and generation of mechanical integration proceduresAbility to establish and work according to integration procedures and to assure the necessary documentationOrganized and structured task approach, high degree of motivation and personal identification with the respective task and projectStrong focus on reaching progress by thinking and communicating in terms of solutions, ability to reach goals also under schedule pressureWillingness for travel, work on mission, work in test campaigns and in shift when the project raises the needExcellent communication skills, ability to work in teams, good written and oral EnglishOptional: Experience of working in the ISO 5 clean room environmentQualified practical apprenticeship Was wir bieten: Zukunftsperspektiven in einem innovativen, wachsenden und agilen UnternehmenEin spannendes Arbeitsumfeld mit vielfältigen KarrierechancenEin tarifliches/ übertarifliches GehaltFlexible Arbeitszeiten sowie mobiles Arbeiten30 Urlaubstage pro Jahr und Sonderurlaub für besondere Anlässe bei Anstellung bei Xtended EngineeringBonusprogramme für Empfehlung und MitarbeiterwerbungTeamevents Xtended Engineering GmbH bringt qualifizierte Ingenieure mit Unternehmen aus der Industrie und Wirtschaft zusammen.
Diese Herausforderungen übernehmen Sie: Independent concept and generation of the mechanical integration and Test procedures at satellite- and instrument level in one of our large space projects in compliance with functional requirements and cost plansAutonomous execution of mechanical integration and test activitiesDefinition of the MGSE in compliance with technical parameters and tost requirements, support the MGSE procurement considering the budget and schedule constraintsSupport of the Project and System Engineering Teams throughout all project phases with regard to mechanical AIT aspects, be prepared to interface with customers and subcontractorsInterface and harmonize with the teams of related disciplines like Optics, Electric, Work preparation and manufacturingPreparation and implementation of standard AIT boards such as TRR, PTR and TRB, participation in project reviewsImpact Assessment on problems and non-conformances with the proper documentation and pro-active seeking of support of other experts when necessaryTimely preparation and compilation of required AIT documents, such as AIT plans, procedures, and test reportsIn cooperation with Product Assurance: keeping log-sheet records, compilation of non-conformance and problem reports Ihr Profil: Diploma in mechanical engineering or similarPractical experience within satellite space projects, in Phase C/D, experience in mechanical integration and generation of mechanical integration proceduresAbility to establish and work according to integration procedures and to assure the necessary documentationOrganized and structured task approach, high degree of motivation and personal identification with the respective task and projectStrong focus on reaching progress by thinking and communicating in terms of solutions, ability to reach goals also under schedule pressureWillingness for travel, work on mission, work in test campaigns and in shift when the project raises the needExcellent communication skills, ability to work in teams, good written and oral EnglishOptional: Experience of working in the ISO 5 clean room environmentQualified practical apprenticeship Was wir bieten: Zukunftsperspektiven in einem innovativen, wachsenden und agilen UnternehmenEin spannendes Arbeitsumfeld mit vielfältigen KarrierechancenEin tarifliches/ übertarifliches GehaltFlexible Arbeitszeiten sowie mobiles Arbeiten30 Urlaubstage pro Jahr und Sonderurlaub für besondere Anlässe bei Anstellung bei Xtended EngineeringBonusprogramme für Empfehlung und MitarbeiterwerbungTeamevents Xtended Engineering GmbH bringt qualifizierte Ingenieure mit Unternehmen aus der Industrie und Wirtschaft zusammen.
In this role, you will conduct quality audits, develop supplier management programs, and collaborate closely with international stakeholders, development teams, and operational units. Benefit from highly complex packaging projects, the highest quality standards, and the expertise of a specialist in pharmaceutical packaging solutions. Your tasks: Select and qualify packaging suppliers to ensure high-quality materials and collaborate with them to choose optimal packaging solutions for pharmaceutical products Lead global harmonization projects to standardize packaging specifications and processes, coordinating closely with international stakeholders from Operations Units and Innovation & Development Establish solid supplier requirements and contract these in supplier quality agreements Conduct quality audits at packaging manufacturers to review processes, improvements, and innovations while ensuring compliance with quality standards and mitigating supply chain risks Support Operational Units in resolving quality issues related to packaging materials through expert risk assessment and corrective actions Foster effective communication and seamless information exchange across the global packaging network, sharing best practices with international experts Contribute to the supplier management program by developing and refining standard operating procedures for supplier management activities Your qualifications Academic background in (Packaging) Engineering, Material Science, or a related technical field, complemented by a minimum of 3 years of relevant industry experience in packaging-related development, production, or quality assurance within the pharmaceutical or medical device sectorExtensive expertise in packaging production technologies and understanding of associated packaging defects for selected categories such as glass, rubber stoppers, thermoplastics, foils, and printed packaging, mainly used for IV solutionsStrong background in assessing primary packaging interactions with products, supported by experience in extractables and leachables studiesCompetencies in quality auditing packaging material suppliers and in-depth knowledge of GxP standards for packaging (e.g., ISO 15378) and regulatory procedures across Europe, the US, and ChinaBusiness fluency in both English and German, plus proficiency with IT tools such as MS Office, SharePoint, and SAP We offer you: A permanent employment contract Competitive salary Flexible working hours and home office options Opportunities for professional development and training Great working atmosphere and a highly motivated team Show us what moves and motivates you - apply now and be part of our inspiring company culture!
Reviews and assesses 3rd party quotations and technical information for compliance as required per the application. Prepares cost estimates for project impact on customer’s line; explains technical functions of machinery and components; articulates competitive advantages of KHS line compared to competitor’s machines.
Reviews and assesses 3rd party quotations and technical information for compliance as required per the application. Prepares cost estimates for project impact on customer’s line; explains technical functions of machinery and components; articulates competitive advantages of KHS line compared to competitor’s machines.
Please send your written application to Jakob Jan Verbraak directly. RAU | CONSULTANTS is not in charge of this search project.
General understanding of financial processes: Order to Cash, Purchase to Pay, etc. Proficient in the use of MS-Office:Word, Excel, PowerPoint Project Management experience or certifications is a plus Bilingual Spanish or Portuguese is a plus. DHL is an equal opportunity employer.
As being part of this team, you will provide end-to-end security consultancy on cloud application and infrastructure, building security into our IT solutions from very beginning. The projects will seek your advice and support along the risk position of the service in its lifecycle. Your work is essential to protect DPDHL group’s information assets in a dynamic threat landscape by secure design.
You can therefore expect to: Identify user needs, design inputs and specifications through participation in the project start-up phase where interaction with key opinion leaders, doctors and other experts worldwide is crucial to fulfil the ambitious innovation targets Be a key influencer in significant development projects within Ambu, either through a mechanical design or lead role Develop new, and further improve existing, mechanical design solutions of components and assemblies as well as optimization of existing designs for Ambu's extensive product portfolio within endoscopy, anesthesiology, and patient monitoring Have the responsibility for the mechanical design and construction of functionalities, parts and assemblies including quality aspects for robust and safe medical products Translate technology concepts into fully working prototypes ready for feasibility testing and process evaluation including documentation Ensure that the component or product is manufacturable in high volume, fulfils function and stays within defined cost framework Ensure continually updated documentation in accordance with the regulations from FDA and ISO certification including FMEA's, risk assessments and tolerance analyses Trust cooperation with internal and external partners.
As part of our team, you will take on the following responsibilities: You are responsible for designing and conducting IT-related audit reviews within the areas and companies of the DKV MOBILITY GROUP, ensuring compliance with internal and external information security requirements and proper operations.You also design and carry out project-related audits and special audits.You prepare meaningful audit reports, evaluate findings, and monitor the implementation of agreed measures.You support the Head of Audit in creating risk-based annual and multi-year audit plans in accordance with the DKV MOBILITY GROUP audit guidelines.
As part of our team, you will take on the following responsibilities: You are responsible for the implementation, administration, monitoring, and maintenance of IT systems and services in a Windows Server environment, in compliance with defined security policies.You analyze and resolve incidents in 2nd- and 3rd-level support within the Windows Server infrastructure.You implement hardening measures to reliably meet regulatory, compliance, and security requirements.In addition, you ensure the continuous development of the systems, with a focus on security, efficiency, and stability, and guarantee stable operations as well as correct and efficient licensing within lifecycle management.You manage and monitor external service providers and ensure a high level of service quality.You conduct market analyses for the selection and evaluation of hardware and software products.You design and implement concepts for server and application operations in compliance with defined security policies.You plan, coordinate, and support IT projects and business sub-projects from realization through testing to rollout.You advise business departments on projects, changes, and adjustments to IT services, systems, and applications.You analyze and evaluate functional, technical, and business requirements and ensure their secure integration.You identify potential for process optimization, automation, and interface improvements and implement them sustainably.