Manager capa management medical devices Stellenangebote
Ihre Jobsuche nach Manager Capa Management Medical Devices Jobs ergab 9 Stellenangebote
Stellenangebote Manager capa management medical devices Jobs bei Neuvoo
Job vom 03.04.2024
Senior Quality Manager QMS and Audit/ CAPA Program
• Stolberg (Rhineland) , North Rhine- Westphalia
Fresenius Medical Care, Global Manufacturing, Quality Supply
[...] Anforderungen an das standortübergreifende Audit Management gemäß den geltenden gesetzlichen und behördlichen Anforderungen, ISO 13485, 21 CFR 820, Medical Device Regulation 2017/ 745 sowie weiterer internationaler Standards Planung, Erstellung, Überwachung und Durchführung interner Audits für alle Standorte inkl. Schulung [...] den MutterkonzernÜberwachung und Koordination des CAPA Systems auf zeitgerechte und prozesskonforme Umsetzung von Korrektur- und Vorbeugemaßnahmen Vor- und Nachbereitung, Koordination und Durchführung des CAPA Review Boards [...] 98- 282, Therapeutic Goods (Medical Devices) Regulations 2002) Ausbildung zum internen Auditor wünschenswert Hohes Qualitätsbewusstsein, Teamfähigkeit und Kommunikationsbereitschaft Ausgeprägte zwischenmenschliche, organisatorische, problemlösende und analytische Fähigkeiten Sehr [...]
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Job vom 15.03.2024
Regulatory Affairs Manager
• Karlsruhe, Baden- Württemberg
EPM Scientific
As a Regulatory Affairs Manager (m/f/d) youll take ownership of all Regulatory topics in a very critical role to the companys future and help to [...] opportunity to join a leading Medical Device company in Germany with a great portfolio of products. ResponsibilitiesRA support during the whole product life cycle (development, certification/ [...] a regulatory perspective Lead/ support CAPA activities from a regulatory perspective Mentor/ coach/ advise on IVD/ MD related processes within the organisation Supporting NRTL certification, Factory [...] Surveillance Activities of IVD/ medical devices Knowledge of ISO 14971 Risk Assessment Activities and Risk Management of medical devices Basic Experience with IEC/ EN 62304 and IEC/ EN 62366Basic Knowledge of IEC/ EN 61010 (preferred) or [...]
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Job vom 24.02.2024
Design Quality Assurance Expert (m/f/d)
• Bad Homburg, Hesse
Fresenius Medical Care, Global Manufacturing, Quality Supply
[...] Assurance and the Product Center Manager role. In your role as Design Quality Assurance Expert (m/f/d) you will be working as a part of product development [...] specification and procedure development, risk management, and design review Provide input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and [...] Product Conformity Main contact for medical devices marked with the CE- mark with a focus on non- active medical devices for Peritoneal Dialysis Ensure that Technical Files [...] needed initiate required activities NC/ CAPA Acts as a Quality Approver for design control related topics and as a Quality Assignee for system related topics Your [...]
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Job vom 16.01.2024
Plant Manager/ Managing Director (m/f/d)
• Göttingen, Lower Saxony
Fresenius Medical Care, North America
Fresenius Medical Care is the world s leading provider of products and services by offering innovative products and treatment concepts of the [...] capacity and cost. Lead local management and development of the plants through efficient and effective employee management, organization, technology, planning, controlling, work processes and deployment of [...] KPI panel, reacting and coordinating CAPA when necessary. Ensure an appropriate organizational structure to reach Plant and Company targets. Coordinate the Local Plant Management to run [...] regulations related to pharmaceuticals, medical devices such as GMP and ISO13485. Previous experience and knowledge of implementing continuous improvement/ lean tools such as Six Sigma, 5- [...]
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Stellenangebote Manager capa management medical devices Jobs bei Jobleads
Job vom 30.03.2024
Lead Auditor- Healthcare
• München, Bayern
[...] Areas of Activity Pre- audit Management of pre- audit documents Preparation of the audit agenda Audit Conducting the audit Post- audit Drafting of audit reports and [...] customer request Evaluation of the CAPA plan CROSS- FUNCTIONAL (INTERNAL AND ETERNAL) RELATIONS Roles and Areas with which links are held Customer Preparation of the audit [...] and travel preparation Audit Customers Manager Collaboration in the technical review of the audit reports. Collaboration following customer requests Collaboration in the auditor qualification process. Reporting [...] in the field of pharmaceuticals, medical devices and/ or cosmetics (QA, Regulatory Affairs, QC, Consulting) Conducting at least 10 supplier audits and/ or internal audits Knowledge of- [...]
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Job vom 29.03.2024
Senior Quality Specialist, Sequencing
• München, Bayern
[...] trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with [...] Job Responsibilities: Responsible for supporting management in developing and implementing Quality Management System (QMS) elements and supporting infrastructure/ tools in compliance with FDA Quality System Regulation [...] Management, Training Management, Supplier Quality, CAPA management, and Post Market Surveillance. Write and revise Quality Systems procedures as needed. Assists with Quality gap assessments and support [...] a plus. ASQ Certified Quality Manager (CQM) , Engineer (CQE) , Auditor (CQA) and/ or Six Sigma Black Belt a plus. Working knowledge of regulations: 21CFR [...]
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Job vom 17.03.2024
Regulatory Affairs Manager
• Karlsruhe, Baden- Württemberg
As a Regulatory Affairs Manager (m/f/d) youll take ownership of all Regulatory topics in a very critical role to the companys future and help to [...] opportunity to join a leading Medical Device company in Germany with a great portfolio of products. Responsibilities RA support during the whole product life cycle (development, [...] a regulatory perspective Lead/ support CAPA activities from a regulatory perspective Mentor/ coach/ advise on IVD/ MD related processes within the organisation Supporting NRTL certification, Factory [...] Surveillance Activities of IVD/ medical devices Knowledge of ISO 14971 Risk Assessment Activities and Risk Management of medical devices Basic Experience with IEC/ EN 62304 and IEC/ EN 62366 Basic Knowledge of IEC/ EN 61010 (preferred) [...]
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Job vom 06.01.2024
Senior Process Engineer (m/f/d)
• Stolberg, Nordrhein- Westfalen
[...] job requisition id R0129195 Fresenius Medical Care is the world s leading provider of products and services by offering innovative products and treatment concepts of the [...] in the manufacture of medical devices for lung and heart treatment. Our Xenios plant in Stolberg manufactures life- sustaining products for the treatment of patients who [...] Handling corrective and preventive actions (CAPA/ Non- conformity) for quality issues including fault analysis, rectification, and documentation. Support in the qualification and validation of newly introduced [...] lean manufacturing methodologies, and quality management systems. 5+ years of professional experience as an engineer in the healthcare sector. Experience as a project manager for development and rationalization projects. Experience in the manufacturing and development of medical devices is advantageous. Desirable experience in Industrial [...]
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Job vom 06.01.2024
Senior Process Engineer (m/f/d)
• Stolberg, Nordrhein- Westfalen
Fresenius Medical Care is the world s leading provider of products and services by offering innovative products and treatment concepts of the [...] in the manufacture of medical devices for lung and heart treatment. Our Xenios plant in Stolberg manufactures life- sustaining products for the treatment of patients who [...] Handling corrective and preventive actions (CAPA/ Non- conformity) for quality issues including fault analysis, rectification, and documentation. Support in the qualification and validation of newly introduced [...] lean manufacturing methodologies, and quality management systems. 5+ years of professional experience as an engineer in the healthcare sector. Experience as a project manager for development and rationalization projects. Experience in the manufacturing and development of medical devices is advantageous. Desirable experience in Industrial [...]
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