Senior Manager, Post-Market Quality & Product Improvement

Are you a proven leader passionate about driving product improvements, enhancing post-market quality processes, and delivering impactful solutions? At Hologic, we are seeking a Senior Manager, Post-Market Quality & Product Improvement to lead post-market investigations, manage quality-related business processes, and implement product changes informed by customer feedback and data. In this key role, you’ll oversee a team of Quality Design Engineers (QDEs), collaborate cross-functionally across the organization, and ensure our products remain safe, compliant, and aligned with customer needs. If you thrive on leadership, strategic project management, and delivering meaningful outcomes in a regulated environment, this opportunity is for you!

Knowledge:

• Comprehensive understanding of Post-Market quality processes, including complaint handling, root cause analysis, and regulatory reporting.
• In-depth knowledge of regulatory requirements such as 21 CFR Part 820, Part 803, ISO 13485:2016, EU MDR, and Canadian MDR.
• Expertise in design verification/validation, GMP, and Quality Systems Regulations.
• Familiarity with risk management processes (e.g., ISO 14971), CAPA, and change control procedures.
• Proficiency in CAD tools (e.g., SolidWorks), statistical analysis software (e.g., MiniTab), and metrics development.

Skills:

• Strong leadership skills to hire, mentor, and develop a high-performing, engaged team.
• Proven project management expertise, including budgeting, resource allocation, and prioritization.
• Advanced analytical skills for trend analysis, root cause investigations, and data-driven decision-making.
• Excellent communication and stakeholder management skills to align goals across technical and business teams.
• Ability to troubleshoot product, process, and component issues using sound engineering principles.
• Skilled in translating post-market data into actionable product and process improvements.
• Familiarity with employee development and fostering a culture of creative problem-solving and innovation.

Behaviors:

• Operates with a strong sense of urgency to address critical product issues, ensuring patient safety and regulatory compliance.
• Collaborative and relationship-driven, building strong cross-functional partnerships to achieve shared objectives.
• Strategic thinker who prioritizes initiatives and drives continuous improvement across processes.
• Detail-oriented and results-driven, delivering high-quality outcomes that exceed expectations.
• Accountable and independent, with the ability to make decisions and resolve conflicts effectively.
• Embraces innovation, fostering a culture of forward-thinking and data-driven improvements.

Experience:

• 10+ years of experience with a Bachelor’s degree, 7+ years with a Master’s degree, or 5+ years with a PhD in engineering or a scientific discipline.
• Management experience in a medical device, pharmaceutical, or heavily regulated industry.
• Demonstrated success in leading post-market investigations, regulatory compliance, and product improvement initiatives.
• Proven experience with complaint management, design transfer, and maintaining Design History Files.
• Beneficial qualifications include PMP certification, Lean Six Sigma Green or Black Belt certification, and experience working with capital equipment in healthcare settings.

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 $145,500-$242,400 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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