Quality Assurance Engineer 2

4 weeks ago

Newark, Delaware, United States Hologic Full time
Quality Assurance Engineer 2

Hologic is seeking a Quality Assurance Engineer 2 to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the quality of our products and processes.

You will work closely with cross-functional teams to investigate and resolve quality issues, develop and implement quality systems, and provide guidance and expertise on root cause evaluation and CAPA effectiveness.

This is a fully qualified, career-oriented, journey-level position that requires a working knowledge and understanding of quality management systems and processes.

Key responsibilities include:

  • Modeling all quality values and supporting others on BSH quality system requirements and standards
  • Collaborating and communicating effectively with junior level employees, peers, and cross-functional teams
  • Coordinating assigned quality efforts and providing support for the Quality Assurance department
  • Facilitating the Corrective & Preventative Action program, process nonconformance, and administration Divisional Management Review
  • Providing guidance and expertise on root cause evaluation and monitoring CAPA effectiveness post closure
  • Performing daily reviews of the CAPA system to determine escalations and coordinating with departments to ensure adequate resourcing
  • Improving the divisional CAPA toolbox, including training and reference materials
  • Working on documentation and activities stemming from the site CAPA Review Board meetings
  • Serving as the divisional point of contact for the CAPA process and providing inputs to global process enhancements and training content
  • Participating in site internal and external quality audits, including support of front and/or back room workstreams

Preferred qualifications include a technical bachelor's degree and 2-4 years of experience in the medical device or IVD industry, or a master's degree and 1-3 years of experience.

This is a bonus-eligible position with an annualized base salary range of $74,500 to $116,600.

Hologic is an equal opportunity employer and welcomes applications from diverse candidates.

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