Provide escalation support for significant quality issues
Ensure timely assessment and containment of quality event
Partner with R&D; to embed quality and manufacturability into new product designs
Support design controls for development and sustaining changes
Participate in design reviews with a strong focus on producibility and risk
Ensure design changes are manufacturable, verifiable, and compliant
Support verification & validation activities with production-representative builds
Support risk management (DFMEA, use-related risk, production risk inputs)
Investigate design-related production issues and quality escapes
Translate production floor feedback into actionable R&D; design improvements
Ensure design documentation and traceability (DHF, requirements, V&V;) are audit-ready
Support audits and inspections related to design controls
Participate in MRB activities, ensuring consistent, compliant, and risk-based disposition of nonconforming material
Ensure sustained compliance with applicable regulations and standards, including ISO 13485, FDA 21 CFR 820 (QSR), EU MDR (as applicable), and relevant IEC standards (e.g., IEC 60601-1)
Collaborate with Supplier Quality and Supply Chain leadership on supplier-related quality issues
Qualifications
A/BS Degree, or equivalent combination of education and experience in a technical discipline is required
3+ years of experience in Design Assurance Quality Engineering, Product Quality, or Manufacturing Quality in medical device industry
Must have working knowledge of quality systems and practices
Must be able to provide guidance to functional teams on quality requirements
Experience in Quality Systems per ISO 13485
Ability to work in a Project Team Environment
Direct experience supporting manufacturing of regulated medical products
Strong working knowledge of CAPA, nonconformance management, change control, and root cause analysis
Excellent verbal and written communication skills
Excellent prioritizing, organizational, and interpersonal skills
Excellent documentation skills including detail-oriented, record maintenance/tracking and understanding of document traceability