Manufacturing Quality Engineer

About the role

West is seeking a Manufacturing Quality Engineer to lead quality activities at one of its manufacturing subcontractors. This fully onsite position supports validation, ensures compliance with GMP/GDP standards, and provides quality oversight for medical device production.

Key responsibilities

• Own all quality activities at the designated subcontractor, ensuring adherence to West procedures and GMP/GDP standards.
• Support validation processes for contract manufacturing and oversee product transfer to production.
• Lead investigations of deviations and non‑conformities, producing root‑cause analysis reports.
• Write, review, and approve pilot documentation, procedures, and production forms.
• Train subcontractor personnel on QA procedures, Voice of the Engineer (VoE), and special processes such as sorting or rework.
• Manage production‑related projects and act as the quality focal point for internal and external initiatives.
• Stop and renew production as required, in coordination with the MQ manager.

Required profile

• Strong “quality first” mindset with a commitment to the highest product standards.
• Experience working in a regulated medical‑device or pharmaceutical manufacturing environment.
• Proven ability to work cross‑functionally and lead multidisciplinary project teams.
• Excellent documentation and audit skills.
• Willingness to work onsite full time.

Required skills

• GMP and GDP compliance
• ISO 13485 quality management systems
• Process validation
• Root‑cause analysis
• Audit execution and reporting
• Quality documentation and control

What we offer

• Inclusive community focused on lifelong learning and professional growth.
• Comprehensive benefit programs supporting physical, mental, emotional, and financial health.
• Opportunities to contribute to life‑saving medical products and sustainability initiatives.