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Senior Quality Engineering Manager
PresencialTiempo completoManufacturing Quality ManagementMedical DevicesPharmaceutical Manufacturing
Lead Quality Engineering, Manufacturing Quality, and Quality Compliance functions at a regulated medical device manufacturing site. The role is onsite four days per week and requires two days per week at a sister site in Shlomi, Israel.
Responsabilidades
- Lead Quality Engineering, Manufacturing Quality, and Quality Compliance teams
- Review and approve design, engineering, validation, risk management, and process documentation
- Provide quality oversight for production lines, process validation, engineering changes, and software validation
- Oversee raw material approval, calibration, batch records, labeling release, and nonconformance management
- Drive Right First Time and Cost of Poor Quality initiatives
- Lead customer complaint investigations, root-cause analysis, risk evaluations, corrective actions, returns management, and complaint trending
- Support adverse-event and hazardous-situation assessments and post-market surveillance
- Ensure quality feedback is incorporated into risk files and process improvements
- Set team priorities, supervise performance, provide training and coaching, and promote a quality-first culture
- Partner with Operations, Engineering, Regulatory Affairs, Supply Chain, customers, and other external stakeholders
Requisitos
- Bachelor’s degree in engineering, science, chemistry, biology, or a related discipline; relevant experience may substitute
- At least 8 years of quality experience in the medical device industry
- At least 5 years of people management experience
- Experience with design controls, process validation, risk management, and customer complaints
- Strong knowledge of ISO 13485, MDR 2017/745, MDSAP, ISO 14971, 21 CFR 820, ISO 9001, and applicable GMP requirements
- Working knowledge of statistical data analysis, validation activities, technical documentation, and risk management
- Strong problem-solving, decision-making, communication, organizational, and technical writing skills
Se valora
- Experience with MasterControl, SAP, SharePoint, statistical tools, and Microsoft Office
- Certified Quality Auditor, CQE, or Lean Six Sigma Black Belt certification
- Experience managing team leaders or remote employees
- Project management experience
- Experience in pharmaceutical or other highly regulated industries
Beneficios
- Benefits supporting physical, mental, emotional, and financial wellbeing
- Lifelong learning, growth, and development opportunities
- Inclusive workplace and sustainability initiatives