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Senior Post Market Quality Engineer

Newark, DE, United States

Marlborough, MA, United States

As a **Senior Post Market Quality Engineer** , you will lead quality engineering efforts for on-market medical devices. This role is responsible for evaluating post-market feedback, investigating complaints, performing risk assessments and root cause analyses, and leading cross-functional teams to implement improvements based on investigation findings. This role sits in **Newark, DE or in Marlborough, MA** and will require onsite presence Monday through Thursday with a remote day on Friday.

Key Responsibilities:

+ Prioritize and own complaint investigations and risk assessments using data analysis, trending, and strategic impact.

+ Lead root cause analyses and direct communication with stakeholders across the organization.

+ Own Health Risk Assessments and drive efficient evaluation of on-market products.

+ Lead cross-functional teams to implement improvements and corrective actions resulting from complaint investigations.

+ Own and lead data analysis and trending of complaints and failure modes, identifying mitigations and presenting findings to internal stakeholders.

+ Lead projects to implement design and process changes, including documentation, testing, and change control.

+ Develop and optimize testing methods for complaint investigations and root cause analysis.

+ Own training and technical guidance for the complaint intake team on complex investigations.

+ Assess product changes for impact on design and risk management, and define supporting documentation requirements.

+ Provide post-market feedback and insights to Operations, Engineering, and R&D to drive product improvement.

+ Apply advanced judgment and expertise to resolve quality issues, ensuring compliance with company policies and procedures.

+ Own on-site investigations at customer locations, leading resolution of field quality issues and upholding the Hologic brand.

+ Present product quality metrics, root cause analyses, and recommendations to Leadership.

+ Lead and participate in internal and external audits, including facility, supplier, Notified Body, and FDA inspections.

+ Own preparation and presentation of materials for monthly Quality Investigation Review boards.

Qualifications

Education:

+ Bachelor’s degree in Engineering required (Mechanical, Electrical, Biomedical, or Biomechanical preferred).

Experience:

+ 5+ years of engineering experience in an FDA-regulated industry.

+ Demonstrated leadership in root cause analysis, complaint investigation, and product development/R&D.

Skills:

+ Deep working knowledge of FDA Quality System Regulations (especially Design Control), ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP.

+ Proven ability to lead teams and own critical tasks to ensure timely and effective resolution.

+ Expertise in reviewing and assessing product/project documentation for compliance, and communicating findings to stakeholders.

+ Advanced proficiency with root cause analysis tools; able to lead investigations for complaints, non-conformances (NCs), and CAPAs.

+ Exceptional communication and presentation skills.

+ Demonstrates strong autonomy, leadership, and ownership in solving complex problems.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!

The annualized base salary range for this role is $92,200 - $144,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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.

As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.

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

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