Senior Product Quality Engineer in Tempsford

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.
• Prioritise 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:

• Bachelor’s degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering.
• Strong level of relevant experience with a bachelor’s 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, sterilisation, 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 women’s 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!