Hologic-posted 3 months ago
$78,300 - $122,400/Yr
Full-time • Mid Level
San Diego, CA
5,001-10,000 employees
Computer and Electronic Product Manufacturing

Are you a quality-driven professional with a passion for validation, process improvement, and regulatory excellence? At Hologic, we are seeking a Quality Engineer II to ensure compliance and quality throughout the manufacturing lifecycle of diagnostic and medical device products. In this role, you will lead validation efforts for analytical methods, equipment, processes, and facilities, while also driving risk management and supporting regulatory submissions. You'll collaborate cross-functionally, contribute to new product introductions, and champion process improvements. If you thrive in a fast-paced environment where you can make a tangible impact on the safety and quality of life-enhancing medical devices, this is the opportunity for you!

  • Lead validation efforts for analytical methods, equipment, processes, and facilities.
  • Drive risk management and support regulatory submissions.
  • Collaborate cross-functionally and contribute to new product introductions.
  • Champion process improvements.
  • 2-5 years of experience in a diagnostic, medical device, biotech, or pharmaceutical company.
  • Hands-on experience with validation activities, including analytical method validation, process validation, and equipment/facility qualifications.
  • Experience with regulatory submissions and understanding of quality systems in regulated industries.
  • Practical experience with risk management, including PFMEAs and process risk assessments.
  • Familiarity with change control processes and electronic document management systems.
  • Proficient understanding of validation methods, including process validation, analytical method validation, cleaning validation, and equipment/facility qualification.
  • Knowledge of risk analysis tools such as PFMEA and process risk assessments.
  • Working knowledge of regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11.
  • Familiarity with change control processes and documentation requirements.
  • Understanding of statistics, Statistical Process Control (SPC), and acceptance sampling plans.
  • Comprehensive training upon joining and continued development throughout your career.
  • Bonus eligibility.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service