Job Description
Senior Product Quality EngineerJoin 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 devicesPrioritize investigations based on product risk, data analysis, trending, and potential business or patient impactWork closely with cross-functional teams including Engineering, Operations, R&D, Quality, Sales, and Service to determine root cause and implement effective corrective actionsConduct health risk assessments and support evaluation of field issues to ensure timely and appropriate responseLead initiatives to implement product or process improvements based on investigation findingsPerform data analysis and trending of complaint and failure data to identify emerging risks and recommend mitigationsSupport CAPA activities where required and help define corrective and preventive actionsLead projects that introduce design or process changes, including testing, documentation updates, and change control activitiesDevelop or improve testing methods used in investigations and failure analysisProvide technical support and guidance to complaint intake teams for complex issuesCollaborate with field teams to investigate and resolve product quality issues at customer sites when necessaryPrepare and present product quality metrics, investigation findings, and recommendations to leadershipParticipate in internal and external audits, including facility audits, supplier audits, and regulatory inspectionsContribute to quality review boards and other forums where product performance and investigations are reviewedWhat we expect:Bachelors degree in Mechanical, Biomedical, Biomechanical, or Electrical EngineeringStrong level of relevant experience with a bachelors degreeExperience in a regulated industry, preferably within medical devices or healthcare technologyStrong knowledge of root cause analysis tools and the ability to lead technical investigationsWorking knowledge of quality and regulatory frameworks such as FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, risk management standards, GMP, and GDPAbility to work independently while collaborating effectively across multidisciplinary teamsStrong analytical thinking with the ability to interpret technical documentation and product dataExcellent written and verbal communication skills, including presenting technical findings to stakeholdersExperience with test method validation, statistical methods, failure analysis, or design of experimentsFamiliarity with reliability, electrical safety, sterilization, packaging, and biocompatibility standardsUnderstanding of verification and validation requirements for regulated productsExperience developing requirements or translating product requirements into measurable specificationsKnowledge of risk-based decision making and statistical analysis techniquesWhy 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!#LI-RH1TPBN1_UKTJ