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Principal Quality Assurance Engineer

Marlborough, MA, United States

Louisville, CO, United States

Are you an experienced quality assurance professional ready to take your career to the next level? 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!

Knowledge:

+ 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.

Skills:

+ Strategic thinking and ability to lead organization-wide initiatives.

+ Strong data analysis and trend interpretation abilities.

+ Excellent written, verbal, and presentation skills tailored for executive-level communication.

+ Proficiency in implementing and controlling Quality Management Systems.

+ Project management skills (certifications are a plus).

+ Ability to mentor and develop senior QA employees.

Behaviors:

+ Independent decision-making and conflict resolution.

+ Collaborative mindset to work cross-functionally with R&D, Regulatory, Marketing, and Quality teams.

+ Proactive and adaptable to regulatory changes and business needs.

+ Strong leadership and ability to inspire teams for continuous improvement.

+ Detail-oriented with a focus on integrity and compliance.

Experience:

+ Minimum 12+ years in the medical device industry.

+ Proven track record in quality system strategy, risk management, and regulatory compliance.

+ Hands-on experience with mergers and acquisitions integration strategies.

+ Demonstrated success in mentoring and developing QA leaders.

+ Experience participating in third-party audits and regulatory inspections.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $132,700-$221,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Agency and Third-Party Recruiter Notice

_Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered._

_Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans._

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