Responsibilities
* provide escalation support for significant quality issues
* ensure timely assessment and containment of quality event
* participate in mrb activities, ensuring consistent, compliant, and risk-based disposition of nonconforming material
* own and oversee quality input to post-release design and process changes (ecos, deviations, waivers, temporary changes)
* ensure thorough change impact assessments are performed to determine verification, validation, revalidation, and documentation requirements
* ensure appropriate risk controls, benefit-risk justifications, and verification activities are implemented and documented
* 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
* ensure supplier changes impacting released products are properly evaluated and approved
* support strategy for incoming inspection, supplier controls, and quality agreements
* act as a key quality leader partnering with manufacturing engineering, design engineering, operations, regulatory affairs, clinical, and supply chain
* lead, mentor, and develop a team of sustaining quality engineers
* set clear priorities, goals, and performance expectations aligned with business and quality objectives
* ensure appropriate staffing, training, and skill development to support production needs.
qualifications
* bachelor's degree or equivalent combination of education and experience in a technical discipline is required.
* english (fluent)
* 5+ years of experience as a quality manager in the medical, aerospace, or automotive sector.
* 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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