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Contractor Combination Product Medical Device (m/f/d) (EN)
[11788]
Combination Products, Design Control , Risk Assessment , Risk Management , Statistics
Job title: Contractor Combination Product Medical Device Industry: Pharma & Medizintechnik Skills: Combination Products,Design Control ,Risk Assessment ,Risk Management ,Statistics Start of project: ASAP Duration of the project : 6 months Project volume: 1008 Hour(s) Location: Basel, Switzerland Tasks: ·Accountable and responsible for Quality engineering product & process development from concept to market launch. ·Provide sound Quality expertise to develop new product and timely address quality resolution for devices, combination product and packaging, and implement end to end effective control strategy and operational control plan. ·Align deliverables within the project cross-functional team and be accountable for the deliverables. ·Structure, manage and approve all quality deliverables related to Design Control, CE marking (if applicable), and Risk Management for the product and maintain their validity both internally and at suppliers. ·Execute all Quality Engineering activities & tasks defined for the product including GMP & ISO documentation management internally and at suppliers, resolution of testing issues, QA processing of deviations, QA approval of Corrective and Preventive Actions (CAPA) as needed, QA processing and assessment of change controls. ·Support to regulatory filings and maintaining inspection readiness. ·Oversight and manage Quality Assurance and Quality Control at device suppliers and tests service providers. ·Support the development, implementation and validation of all test methods required for functionally characterize products. ·Ensure qualification of Combination Product assembly process internally and at COMs. ·Effectively collaborate with all project functions and communicate quality requirement for industrialization of the product. ·Maintain an overview of applicable quality standards and their evolution within the related business. ·Ensure compliance with all local, state, federal, andcompany's quality policies, procedures and practices, safety regulations, policies, and procedures. ·Keep the company's Quality Systems up to date with medical devices and Combination Product requirement. ·Notify management of potential quality and regulatory issues. Qualifications: ·University degree in related quality engineering field, advanced degree desired. ·Minimum 7 years of experience in quality engineering or technical combination product development & industrialization with 5 years in medical or pharmaceutical industry with successful track record of delivering quality products to market. ·Demonstrated medical device, combination product and packaging development quality engineering skills. ·Broad and deep understanding of quality product development processes, regulatory, and quality / risk management systems (ISO 13485, MDR, 21CFR820, ISO 14971…) ·Demonstrated supplier quality management skills. ·Advanced problem-solving skills and statistical knowledge. ·Advanced skills in method validation. ·Sound knowledge of drug product manufacturing, control, packaging and distribution procedures. ·Strong interpersonal and influencing skills. ·Excellent verbal and written communication skills in English. ·Ability to manage multiple tasks with competing priorities. ·Entrepreneurial mind set combined with cost consciousness.
Skills: Combination Products,Design Control ,Risk Assessment ,Risk Management ,Statistics
- Accountable and responsible for Quality engineering product & process development from concept to market launch.
- Provide sound Quality expertise to develop new product and timely address quality resolution for devices, combination product and packaging, and implement end to end effective control strategy and operational control plan.
- Align deliverables within the project cross-functional team and be accountable for the deliverables.
- Structure, manage and approve all quality deliverables related to Design Control, CE marking (if applicable), and Risk Management for the product and maintain their validity both internally and at suppliers.
- Execute all Quality Engineering activities & tasks defined for the product including GMP & ISO documentation management internally and at suppliers, resolution of testing issues, QA processing of deviations, QA approval of Corrective and Preventive Actions (CAPA) as needed, QA processing and assessment of change controls.
- Support to regulatory filings and maintaining inspection readiness.
- Oversight and manage Quality Assurance and Quality Control at device suppliers and tests service providers.
- Support the development, implementation and validation of all test methods required for functionally characterize products.
- Ensure qualification of Combination Product assembly process internally and at COMs.
- Effectively collaborate with all project functions and communicate quality requirement for industrialization of the product.
- Maintain an overview of applicable quality standards and their evolution within the related business.
- Ensure compliance with all local, state, federal, andcompany's quality policies, procedures and practices, safety regulations, policies, and procedures.
- Keep the company's Quality Systems up to date with medical devices and Combination Product requirement.
- Notify management of potential quality and regulatory issues.
- University degree in related quality engineering field, advanced degree desired.
- Minimum 7 years of experience in quality engineering or technical combination product development & industrialization with 5 years in medical or pharmaceutical industry with successful track record of delivering quality products to market.
- Demonstrated medical device, combination product and packaging development quality engineering skills.
- Broad and deep understanding of quality product development processes, regulatory, and quality / risk management systems (ISO 13485, MDR, 21CFR820, ISO 14971…)
- Demonstrated supplier quality management skills.
- Advanced problem-solving skills and statistical knowledge.
- Advanced skills in method validation.
- Sound knowledge of drug product manufacturing, control, packaging and distribution procedures.
- Strong interpersonal and influencing skills.
- Excellent verbal and written communication skills in English.
- Ability to manage multiple tasks with competing priorities.
- Entrepreneurial mind set combined with cost consciousness.
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