Quality Manager
On-site · Boston, Massachusetts, United States
Job Summary
Quality Manager leading manufacturing quality systems, audits, supplier and customer quality initiatives, and lab operations. Drives continuous improvement, oversees audits, manages non-conformance reductions, handles return authorizations, and ensures regulatory compliance while collaborating with internal partners to close quality gaps and training needs. Requires ISO 9001 experience, ISO 13485 familiarity, and a certified auditor background; preferred knowledge of fabric medical device or textile materials; responsible for overseeing the on-site laboratory and personnel appraisals.
Required Qualifications
- Bachelor's in business or engineering (or equivalent work experience)
- 3+ years of Quality Management experience in manufacturing
- Fabric medical device or textile materials knowledge a plus
- ISO 9001 mastery and familiarity with ISO 13485
- Certified Auditor or willingness to become one
- Microsoft Office Suite proficiency and MRP system understanding
- Strong time management skills to prioritize and deliver
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