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Form of work
SalaryMTS is a contract manufacturer of medical devices and is seeking a Quality Assurance and Regulatory Manager. You will be responsible for maintaining the MTS Quality Management System (QMS) and ensuring compliance. You will also be responsible for leading FDA and other required audits, such as ISO 13485, internal and customer audits.
- Supervises Quality Assurance team.
- Serves as Management Representative.
- Responsible for ensuring full compliance with MTS QMS.
- Leads FDA, ISO and customer audits.
- Chairs CAPA Review Board meetings.
- Responsible for ensuring metrics are established, maintained and reported to Executive Management.
- Plans, develops and presents Management Review meetings.
- Assists in investigations and root cause analysis.
- Approves engineering protocols and reports.
- Develops and executes continuous improvement activities.
Qualifications
- Bachelor of Science Degree in Operations, Engineering or related field.
- Minimum of ten (10) years’ experience in regulated quality systems.
- Minimum of five (5) years’ experience in a supervisory role.
- Familiar with ISO13485:2016 and / or 21 CFR 820 requirements.
- Experience with FDA audits.
Job Type: Full-time
Pay: $85,000.00 - $125,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
Work Location: In person
