Senior Manager, Quality Engineering

About the role

West Pharmaceutical Services is hiring a Senior Manager, Quality Engineering in Ra'anana, Israel. The role leads the site's Quality Engineering, Manufacturing Quality and Quality Compliance functions, overseeing engineering quality processes, design transfer, process validation, production quality oversight and customer complaints handling. It is a hybrid position with at least 3 days per week onsite, and travel to the sister site in Shlomi is required depending on where you live.

Key responsibilities

• Lead review and approval of technical documentation: DMR, DHF elements, IQ/OQ/PQ, process validations, product specifications, risk management files, test methods, protocols, design transfer documentation and more.
• Provide quality oversight for new production lines, process validations, engineering changes and software validations.
• Oversee production quality controls: raw material and calibration approvals, DHR and batch record review, labeling release and nonconformance management.
• Drive Right First Time and Cost of Poor Quality initiatives and provide escalation support and problem-solving guidance.
• Lead customer complaints handling: investigation, root cause analysis, risk-based evaluation, corrections and corrective actions, RMA/RGA management, complaint trending and reporting, and interface with customers on QA-related issues.
• Support RA in identifying adverse events and hazardous situations, and feed findings into risk management files.
• Set priorities and objectives for Quality Engineering and Compliance teams, supervise performance, training and development, coach staff and promote a "Quality First" culture.

Required profile

• B.Sc. in Engineering, Science, Chemistry, Biology or a related discipline; relevant experience may be considered in lieu of the degree.
• 8-10+ years of experience in quality roles within the medical device industry.
• 5+ years of people management experience, preferred experience managing team leaders.
• Experience in the medical device or pharmaceutical industry, and previous leadership experience, preferably managing remote employees.

Required skills

• Knowledge of ISO 13485, MDR 2017/745, MDSAP, ISO 14971 and 21 CFR 820.
• Preferred: MasterControl, SAP, SharePoint, statistical tools, Microsoft Office Suite, Lean Six Sigma Black Belt, CQA/CQE or Certified Quality Auditor certifications.
• Strong communication, writing and presentation skills, and the ability to work under pressure and multi-task.

What we offer

• Professional growth through training, tuition assistance, leadership development and skill-certification programs.
• Paid time off covering vacation, personal and holiday leave.
• Volunteer opportunities through the West without Borders initiative and other charitable programs.