Post Market Quality Engineer at 613.5310.0200 GYNESONICS - CORPORATE SALES MID-ATLANTIC REGION, US

As a Post Market Quality Engineer, you will provide quality engineering support 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 and will require onsite presence Monday through Thursday with a remote day on Friday. 

Key Responsibilities:

• Prioritize complaints and investigations using product risk, data analysis, trending, and strategic impact.
• Own complaint investigations and associated root cause analyses, coordinating collaboration and communication with stakeholders.
• Partner with cross-functional teams to communicate findings, determine if CAPA is required, and scope recommended changes.
• Perform Health Risk Assessments and coordinate with internal teams to ensure efficient and effective evaluation of on-market products.
• Lead cross-functional teams in implementing improvements or corrections resulting from complaint investigations.
• Perform data analysis and trending of complaints and failure modes, identify mitigations for threshold risks, and prepare/present findings to internal stakeholders.
• Lead projects to implement design or process changes, including updating drawings, fixtures, tooling, testing, and change control documentation.
• Develop and improve testing methods used during complaint investigations and root cause activities.
• Train and support the complaint intake team by providing technical expertise for complex investigations.
• Assess product changes for impact on design and risk management, and determine supporting information required for implementation.
• Provide post-market feedback to Operations, Engineering, and R&D, leveraging complaint trends and other forums to drive continuous product improvement.
• Apply company policies and procedures to resolve a variety of issues, developing professional expertise and judgement.
• Perform on-site investigations at customer locations, collaborating with field-based teams (sales, service) to urgently resolve field quality issues while upholding the Hologic brand.
• Present product quality metrics to Leadership, explain root causes, and recommend actions/resolutions.
• Participate actively in internal and external audits, including facility, supplier, Notified Body, and FDA inspections.
• Support monthly Quality Investigation Review boards by preparing and presenting relevant materials.
• Travel to customer sites - 25% travel 

Qualifications

Education:

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

Experience:

• 2–5 years of experience in engineering, ideally within an FDA-regulated industry.
• Experience in root cause analysis or product development/R&D is a plus.

Skills:

• Solid working knowledge of FDA Quality System Regulations (especially Design Control), ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP.
• Ability to work effectively on project teams, including leading critical tasks to ensure timely and appropriate resolution.
• Skilled at reviewing and assessing product/project documentation for compliance, with strong communication of findings and recommendations.
• Proficient with root cause analysis tools and techniques; able to lead investigations for complaints, non-conformances (NCs), and CAPAs.
• Strong communication and presentation skills.
• Demonstrates intermediate autonomy and independence, requiring minimal oversight when 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 $72,100- $112,800 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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