Quality Assurance Specialist III
5 hours ago
We are seeking a skilled Quality Technician III to join our quality assurance team in Billerica, MA. In this role, you will be responsible for creating and maintaining documentation systems that ensure our products meet the highest standards of quality and compliance.
Responsibilities- Perform review of paper production records to ensure compliance to internal QMS requirements, 820 CFR Part 11 and other regulatory requirements as applicable.
- Perform rework assessments on capital systems.
- Perform analyses, inspection, and tests of raw materials, packaging materials, quantitative assays on samples, and/or finished products from manufacturing, to ensure quality standards and compliance to customer and regulatory requirements, and tolerance specifications for the chemical or physical property.
- Perform a variety of qualitative tests or qualitative assays on samples, and to aid in maintenance and certification of test instruments and apparatus to ensure compliance.
- Perform required inspections, checks, analysis and documentation of studies.
- Prepare and monitor quality statistics and reports.
- Reviews production records for conformance to procedures.
- Conducts non-conformance tests of manufactured, packaged or tested product.
- High School Diploma or Equivalent
- Minimum of 4 years of relevant work experience
- Proven experience of 3-5 years in Quality within a regulated industry such as medical devices or Pharma is required for this role
- Proven success collaborating with cross-functional teams
- Proficient in problem resolution
- Strong written and verbal communication
Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Salary ranges for U.S (excl. PR) locations (USD): $50,800.00 - $76,200.00
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