Supplier Quality Engineer Jobs

About The Position

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy or related field (Master’s preferred).
• Formal auditor training (ISO 13485, GMP) required or equivalent experience; Lead Auditor certification preferred.
• 5–8 years in Supplier Quality/Quality Engineering in medical device and/or pharma. Pharma/Biologics preferred.
• Proven experience leading supplier audits, managing CAPA, and implementing QTAs.
• Working knowledge of FDA 21 CFR Parts 820/210/211/600/610/680, EU GMP, ISO 13485, ISO 14971.
• Experience with eQMS (Veeva or ENNOV is a +), supplier performance dashboards, and RACI implementation.
• Fluent in English; strong communication and stakeholder influencing skills.

Nice To Haves

• Master’s degree
• Lead Auditor certification
• Pharma/Biologics experience
• Experience with Veeva or ENNOV eQMS
• Experience with supplier performance dashboards
• Experience with RACI implementation

Responsibilities

• Support the audit program: annual plan, execution, reporting, and follow-up of CAPA effectiveness.
• Maintain supplier risk assessment, segmentation, and performance reviews; drive improvement actions with suppliers.
• Lead QTA lifecycle: creation, review, negotiation support with Procurement, and periodic updates; ensure RACI is defined and applied.
• Support SOPs for Supplier Management and ensure alignment with global procedures, coach teams on process adherence.
• Ensure readiness for inspections (e.g., FDA, EU) and PAI: maintain supplier files GMP certificates, monitor expirations, and prepare audit/inspection evidence.
• Provide quality engineering support (incoming controls, sampling plans, problem solving 8D/5Why, data analysis) to prevent recurrence of issues.