Quality Assurance Engineer

2 weeks ago


Plymouth, United States GForce Life Sciences Full time

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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