Job description

Join Hologic , a global leader in women's health , dedicated to developing innovative medical technologies that help detect, diagnose, and treat disease with greater accuracy and confidence. Headquartered in Marlborough, MA, Hologic's solutions impact millions of women worldwide across breast health, gynecologic health, and diagnostics. As part of our team, you'll contribute to products that improve patient outcomes and advance the standard of care, helping fulfill our mission of enabling healthier lives everywhere. Position Summary Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Sr. Product Quality Engineer to provide engineering support for on-market medical devices. In this role, you’ll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you’ll drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction. If you’re a proactive problem-solver with a strong background in quality engineering, we encourage you to apply and make a difference in healthcare innovation. The Sr. Product Quality Engineer provides advanced quality engineering support across the post market life cycle. This role leads cross-functional quality initiatives, support field engineering and complaint handling processes and teams, and ensures processes comply with applicable regulations, standards, and Hologic’s Quality Management System. Operating with minimal supervision, the position drives investigations, root cause analysis, risk management, and continuous improvement while mentoring junior engineers. Knowledge: • Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP. • Familiarity with root cause analysis tools, risk management principles, and compliance frameworks. • Preferred knowledge of test method validation, statistical methods, design of experiments (DOE), and industry standards related to reliability, sterilization, packaging, and biocompatibility. Skills: • Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues. • Strong data analysis and trending skills to identify risks, assess failure modes, and recommend mitigations. • Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership. • Ability to assess product changes for design and risk management impact, ensuring compliance and quality standards are maintained. • Proficiency in developing or improving testing methods for complaint investigations and technical activities. • Experience collaborating with cross-functional teams, including Operations, R&D, and Engineering, to drive product and process improvements. • Preferred: Familiarity with verification and validation requirements and the development of testable and measurable specifications. Behaviors: • Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements. • Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes. • Collaborative and team-oriented, building productive relationships across functions to drive quality improvements. • Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution. • Continuous improvement mindset, driving process optimization and identifying opportunities to enhance product quality. Experience: • Bachelor’s degree in engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related discipline) required. • 5+ years of experience in quality engineering, product development, or R&D, preferably in an FDA-regulated industry. • Hands-on experience in complaint investigations, root cause analysis, and CAPA activities. • Familiarity with internal and external audits, including Notified Body and FDA 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 $98,000-$135,100 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. #LI-MP3

Requirements

Must-haves

Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP.
Familiarity with root cause analysis tools, risk management principles, and compliance frameworks.
Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues.
Strong data analysis and trending skills to identify risks, assess failure modes, and recommend mitigations.
Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership.
Ability to assess product changes for design and risk management impact, ensuring compliance and quality standards are maintained.
Proficiency in developing or improving testing methods for complaint investigations and technical activities.
Experience collaborating with cross-functional teams, including Operations, R&D, and Engineering, to drive product and process improvements.
Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements.
Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes.
Collaborative and team-oriented, building productive relationships across functions to drive quality improvements.
Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution.
Continuous improvement mindset, driving process optimization and identifying opportunities to enhance product quality.
Bachelor’s degree in engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related discipline) required.
5+ years of experience in quality engineering, product development, or R&D, preferably in an FDA-regulated industry.
Hands-on experience in complaint investigations, root cause analysis, and CAPA activities.
Familiarity with internal and external audits, including Notified Body and FDA inspections.
Why join Hologic?
Agency and Third-Party Recruiter Notice
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

Nice-to-haves

Preferred knowledge of test method validation, statistical methods, design of experiments (DOE), and industry standards related to reliability, sterilization, packaging, and biocompatibility.
Preferred: Familiarity with verification and validation requirements and the development of testable and measurable specifications.

Application prep

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