Senior Supplier Quality Engineer
Core
Maintaining and continuously improving the quality of materials and components procured by the business, overseeing supplier performance and compliance with regulatory standards.
Role type
Senior Supplier Quality Engineer (SQE)
Builds
Supplier quality control plans, audit reports, and corrective action strategies for medical device components.
Domain
Medical device manufacturing / Quality Engineering
Deliverable
client delivery
Required skills
Supplier qualification and audit execution, root cause analysis, failure analysis, statistical sampling plans, Six Sigma methodology, regulatory compliance (21 CFR 820, GMP, ISO 13485), technical drawing interpretation, change control management, PPAP/MSA review.
Preferred skills
Lean Six Sigma certification, Quality Engineering certification, international travel for audits.
Technologies
GD&T, 21 CFR 820, GMP, EN ISO 13485, ISO 14971, PPAP, MSA.
Responsibilities
Conduct comprehensive audits and capability assessments of supplier facilities; analyze supplier performance data to identify trends; follow up on corrective actions for quality issues; support or execute change orders for process improvements; review and participate in component qualifications (PPAP), MSA, and supplier control plans; develop monthly supplier quality trend analysis (Scorecards); lead the supplier qualification and maintenance process including new supplier introduction.
Seniority
Senior, hands-on IC