Quality Engineer 3

Hologic Careers • Londonderry, NH

119d • $83,000 - $129,000

About The Position

At Hologic, we are seeking a Quality Engineer 3 to provide advanced expertise throughout the manufacturing lifecycle. As a key liaison between design transfer, production, and continuous improvement, you’ll play a critical role in driving quality initiatives, ensuring compliance, and enhancing operational excellence. Operating with minimal direction, you’ll lead investigations, manage validations, and mentor junior engineers, all while ensuring robust, compliant processes aligned with regulatory standards and industry best practices. If you’re ready to make an impact by delivering safe, reliable, and high-quality medical devices, we want you on our team!

Requirements

• 7+ years of experience as a Quality Professional in the medical device industry or equivalent combination of education and experience.
• In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP requirements.
• Expertise in risk management principles, including ISO 14971 and Process Failure Mode and Effects Analyses (PFMEAs).
• Advanced understanding of statistical tools, including Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE).
• Strong familiarity with Quality Management Systems (QMS) and compliance activities.

Nice To Haves

• ASQ Certified Quality Engineer (CQE) certificate and/or Six Sigma Certification preferred.

Responsibilities

• Lead investigations and manage validations.
• Mentor junior engineers.
• Drive quality initiatives and ensure compliance.
• Enhance operational excellence.
• Manage Nonconforming Events (NCEs) and implement effective CAPAs.
• Analyze quality system metrics and product quality data to identify trends.
• Author, review, and approve technical reports for Test Method Validations and Process Validations.
• Manage seamless design transfers to production and product transfers between manufacturing sites.

Benefits

• Comprehensive training upon joining and continued development throughout your career.
• Bonus eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees