Quality Engineer 3

Hologic • Londonderry, NH

118d • $83,000 - $129,000

About The Position

Are you an experienced quality professional with a passion for delivering excellence in the medical device industry? 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.
• In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP requirements.
• Expertise in risk management principles, including ISO 14971 and PFMEAs.
• Advanced understanding of statistical tools, including Six Sigma, SPC, and DOE.
• Strong familiarity with Quality Management Systems (QMS) and compliance activities.
• Proven ability to lead root cause investigations and implement sustainable corrective actions.

Nice To Haves

• ASQ Certified Quality Engineer (CQE) certificate.
• Six Sigma Certification.

Responsibilities

• Lead investigations and manage validations in the manufacturing lifecycle.
• Act as a liaison between design transfer, production, and continuous improvement.
• Drive quality initiatives and ensure compliance with regulatory standards.
• Mentor junior engineers and guide them in their professional development.
• 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 Nonconforming Events (NCEs) and implement effective CAPAs.
• Collaborate cross-functionally to manage design transfers and product transfers.

Benefits

• Comprehensive training upon joining and continued development throughout your career.
• Annualized base salary range of $83,000-$129,000, bonus eligible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing