Responsibilities
* 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)
* collaborating 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 quality engineering, product quality, or manufacturing quality within a regulated 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
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