Senior Quality Assurance Engineer
Posted on 2/6/2024
Billerica, MA, USA
Experience Level
QA & Testing
  • Bachelor's Degree in related field (Biomedical, Software, Electrical, Mechanical Engineering or equivalent)
  • 4+ years experience in a Quality function within the Medical Device, Biotechnology, Life Sciences or similar discipline
  • Experience in in-vitro diagnostic manufacturing environment desired
  • Awareness of QSR and ISO regulatory requirements
  • Proficiency with standard business tools: word processing, presentations, spreadsheets, internet software, manufacturing software, database software
  • Support gathering, analyzing, and translating internal and external customer feedback to improve product quality and overall customer satisfaction
  • Apply knowledge of Design Control principles and quality engineering to positively influence new product development and sustaining efforts
  • Establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards
  • Optimize and implement manufacturing processes, procedures in support of process flow and value stream mapping improvements for existing products
  • Contribute to internal and supplier audits by consultancy or participation
  • Contribute to Defect-, CAPA-, and Change Management activities
  • Support communication to customers as required based on product issues in the field
  • Prioritize and maximize the impact of product quality improvement projects
  • Ensure product quality data is well communicated and well understood by all key stakeholders
Desired Qualifications
  • Advanced degree is a plus (M.S. in a Life Science, or equivalent)
  • Experience in in-vitro diagnostic manufacturing environment
  • Awareness of QSR and ISO regulatory requirements