Key Responsibilities:
• Investigate and report adverse events or device issues per FDA and international regulations.
• Manage nonconforming materials (NCRs) and customer complaints, including root cause analysis, disposition, and communication with customers/suppliers.
• Oversee Supplier Corrective Action Requests (SCAR), coordinate with suppliers on investigations and corrective actions.
• Support CAPA processes: lead investigations, root cause analysis, action plans, and verify effectiveness.
• Qualify and audit new/current suppliers, track performance, issue scorecards, and manage supplier relationships.
• Lead Risk Management tasks.
• Conduct Gage R&R studies and validation activities.
• Create statistical sampling plans for inspections/testing.
• Ensure compliance with cGMP, QSR, ISO 13485, ISO 14971, EU MDR/MDD, and other relevant standards.
Minimum Qualifications:
• Bachelor’s in Engineering, Science, or Math
• 3+ years in Quality Engineering in a medical device manufacturing (FDA/ISO regulated)
• Premarket quality engineering experience required
• Strong knowledge of ISO 13485, FDA QSR, ISO 14971, EU MDR, and related standards
• Skilled in statistical methods and sampling
• Ability to read drawings and apply GD&T
• Experience with technical writing and quality audits
• Familiarity with manufacturing processes, Six Sigma, Lean, etc.