Principal Quality Assurance Engineer

Hologic Careers • Marlborough, MA

123d • $132,700 - $221,200

About The Position

At Hologic we’re searching for a Principal Quality Assurance Engineer to lead strategic initiatives that optimize and enhance our Quality Management System. In this role, you’ll be responsible for ensuring compliance with global regulations, championing advanced quality tools, and driving continuous improvement across our divisional and global operations. If you’re passionate about mentoring leaders, solving complex challenges, and shaping the future of healthcare quality, we want to hear from you!

Requirements

• In-depth understanding of FDA Quality System Regulations, ISO 13485, and Medical Device Directive.
• Expertise in compliance issues and regulatory expectations.
• Advanced knowledge of Quality Management Systems and risk-based approaches.
• Familiarity with global regulations and industry best practices.
• Awareness of digital quality tools, AI-driven analytics, and advanced quality monitoring solutions.
• Minimum 12+ years in the medical device industry.
• Proven track record in quality system strategy, risk management, and regulatory compliance.

Nice To Haves

• Project management skills (certifications are a plus).
• Hands-on experience with mergers and acquisitions integration strategies.
• Demonstrated success in mentoring and developing QA leaders.

Responsibilities

• Lead strategic initiatives to optimize and enhance the Quality Management System.
• Ensure compliance with global regulations.
• Champion advanced quality tools and drive continuous improvement across operations.
• Mentor and develop senior QA employees.
• Participate in third-party audits and regulatory inspections.

Benefits

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

What This Job Offers

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