Quality Assurance Engineer
2 weeks ago
Internal Title: Engineer Sr., Quality
Duration: 7-month contract
Location: Onsite in Plymouth,MN
A Senior Quality Assurance Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system.
Responsibilities
- Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.
- Lead on-time completion of Quality Assurance (QA) engineering deliverables.
- Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.
- Works with and influences key stakeholders to develop and maintain QA procedures, forms, and systems.
- Develop and lead training for QA systems.
- Influence and guide other team members with product review and analysis for QA activities. Maintain databases and record storage for QA systems.
- Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
Qualifications
- Bachelor's Degree in related field
- 5 years’ experience in quality engineering
- Project Engineer management experience – leading two projects
- Process monitoring implementation experience required (looking at critical quality features, look at severity modes, FMEA, implement software as needed)
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