Senior Product Quality Engineer
Join a team where your expertise directly improves the quality, safety, and performance of life-changing medical technology. As a Senior Product Quality Engineer, you will help ensure that devices used in healthcare settings worldwide meet the highest standards of reliability, safety, and regulatory compliance.
This role offers the opportunity to solve complex technical challenges, collaborate across engineering and operational teams, and drive meaningful improvements to products already supporting patients and clinicians in the field.
What to expect:
Lead complaint investigations and perform root cause analysis to identify and resolve product issues affecting on-market devices
Prioritize investigations based on product risk, data analysis, trending, and potential business or patient impact
Work closely with cross-functional teams including Engineering, Operations, R&D, Quality, Sales, and Service to determine root cause and implement effective corrective actions
Conduct health risk assessments and support evaluation of field issues to ensure timely and appropriate response
Lead initiatives to implement product or process improvements based on investigation findings
Perform data analysis and trending of complaint and failure data to identify emerging risks and recommend mitigations
Support CAPA activities where required and help define corrective and preventive actions
Lead projects that introduce design or process changes, including testing, documentation updates, and change control activities
Develop or improve testing methods used in investigations and failure analysis
Provide technical support and guidance to complaint intake teams for complex issues
Collaborate with field teams to investigate and resolve product quality issues at customer sites when necessary
Prepare and present product quality metrics, investigation findings, and recommendations to leadership
Participate in internal and external audits, including facility audits, supplier audits, and regulatory inspections
Contribute to quality review boards and other forums where product performance and investigations are reviewed
What we expect:
Bachelors degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering
Strong level of relevant experience with a bachelors degree
Experience in a regulated industry, preferably within medical devices or healthcare technology
Strong knowledge of root cause analysis tools and the ability to lead technical investigations
Working knowledge of quality and regulatory frameworks such as FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, risk management standards, GMP, and GDP
Ability to work independently while collaborating effectively across multidisciplinary teams
Strong analytical thinking with the ability to interpret technical documentation and product data
Excellent written and verbal communication skills, including presenting technical findings to stakeholders
Experience with test method validation, statistical methods, failure analysis, or design of experiments
Familiarity with reliability, electrical safety, sterilization, packaging, and biocompatibility standards
Understanding of verification and validation requirements for regulated products
Experience developing requirements or translating product requirements into measurable specifications
Knowledge of risk-based decision making and statistical analysis techniques
Why Join Hologic?
Make a Difference: Impact millions of lives by ensuring the highest standards in womens health.
Grow Your Career: Thrive in a global, innovative, and supportive environment.
Drive Change: Be part of a company that values your ideas and expertise.
Ready to make your mark? Apply now!
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