Manufacturing Quality Engineer

About the role

West Pharmaceutical Services is hiring a Manufacturing Quality Engineer for a fully onsite position in Shlomi, Israel, working 5 days a week. The role owns all production activities at one of the company's subcontractors, supports validation of contract manufacturing, provides quality oversight to the engineering department and acts as the quality focal point for production and machine-related projects. No relocation or sponsorship is provided.

Key responsibilities

• Ensure products meet quality standards and hold them to the highest standard, following company procedures and GMP/GDP standards.
• Write, review and approve pilot documents, department and production procedures and forms.
• Lead investigations of deviations and nonconformities and create analysis reports.
• Train subcontractors according to QA procedures and VoE, and support special processes such as sorting or rework.
• Own production activities at the subcontractor, including stopping and renewing production with MQ manager approval.
• Provide quality oversight of validation activities and lead pilot processes, including change and approval of quality aspects in pilot protocols and reports.
• Manage production-related projects and act as MQ focal point in internal and external projects such as Data Integrity, CoPQ and production improvement plans.

Required profile

• B.Sc. in Engineering or Science, or equivalent relevant work experience.
• Minimum 3 years of experience in medical device quality and production lifecycle.
• Experience with production processes, process controls, subcontractor interfaces and customer expectations.
• Experience with medical device validation, risk management and product transfer to production.

Required skills

• Working knowledge of quality systems such as ISO 13485, 21 CFR 820, ISO 14971 and MDSAP.
• Preferred: experience with MasterControl, SharePoint and Teamcenter, and certification as an auditor.
• Preferred: problem-solving including root cause analysis, and experience in medical device/pharma.