Post Market Quality Engineer
Newark, DE, United States
Marlborough, MA, United States
**Product Quality Engineer - Breast and Skeletal Health Division**
**Location: Marlborough, MA (Hybrid )**
Are you passionate about driving product quality and ensuring the safety and effectiveness of life-changing medical devices? Join Hologic's Breast and Skeletal Health Division as a **Post Market Quality Engineer** and play a pivotal role in supporting on-market devices through rigorous investigation, root cause analysis, and collaborative problem-solving.
As a **Post Market Quality Engineer** , you will provide engineering support for on-market medical devices, performing evaluations, investigations, risk assessments, and root cause analyses in response to post-market feedback and field complaints. You'll lead cross-functional teams to implement improvements or corrections, ensuring our products continue to meet the highest standards of quality, safety, and compliance.
**Key Responsibilities:**
+ Prioritize complaints and investigations based on product risk, data analysis, and strategic impact.
+ Own investigations and root cause analyses, collaborating and communicating with stakeholders.
+ Execute Health Risk Assessments and coordinate evaluations of on-market products.
+ Lead cross-functional teams to implement corrective actions and improvements based on investigation results.
+ Analyze and trend data related to complaints and failures, identifying mitigation strategies and presenting findings to internal stakeholders.
+ Lead projects to implement design or process changes, including drawing updates, fixture/tooling updates, testing, and change control documentation.
+ Develop or improve testing methods used during complaint investigations and root cause activities.
+ Train and support the complaint intake team with technical expertise.
+ Assess product changes for impact to design and risk management, determining supporting information required for implementation.
+ Provide post-market feedback to Operations, Engineering, and R&D to improve device design and manufacturing.
+ Conduct field investigations in partnership with sales and service teams, ensuring timely resolution of field quality issues.
+ Present product quality metrics to leadership, explaining root causes and recommending actions.
+ Participate in internal and external audits, including FDA inspections and supplier audits.
+ Support monthly Quality Investigation Review boards.
**Qualifications & Experience:**
+ Bachelor's degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering required.
+ 2-5 years' experience in engineering, ideally within an FDA-regulated industry.
+ Experience in root cause analysis or product development/R&D is beneficial.
**Skills & Attributes:**
+ Working knowledge of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP.
+ Strong ability to work on and lead project teams, ensuring timely and effective resolution of tasks.
+ Skilled in assessing documentation for compliance and effectively communicating assessments.
+ Experienced with root cause analysis tools and leading investigation activities (complaints, NCs, CAPAs).
+ Good communication and presentation skills.
+ Ability to work with autonomy on complex problems, requiring analysis of a variety of factors.
**Preferred Skills:**
+ Familiarity with test method validation, statistical methods, and design of experiment.
+ Understanding of reliability, electrical safety, sterilization, packaging, and biocompatibility standards.
+ Experience with verification and validation requirements for regulated products.
+ Knowledge of requirements analysis, risk-based, and statistical analysis concepts.
**Physical & Travel Requirements:**
+ Ability to sit, stand, walk, reach, stoop, kneel, crouch, or crawl.
+ May lift/carry up to 40 pounds; exposure to mechanical parts, chemicals, blood, high voltage electronics, and radiation.
+ Ability to work in clean room, controlled, and/or dark room environments.
+ Travel to customer sites as required (<25%).
**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 $78,000 - $122,100 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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