Quality Assurance Engineer 2

Join Hologic as a Quality Engineer in a regulated medical device environment, responsible for ensuring products, processes and systems meet internal quality requirements and external regulatory standards (e.g., FDA, ISO). The position supports Operations, Engineering and R&D, focusing on defect prevention, continuous improvement, and robust manufacturing practices.KnowledgeQuality Management Systems (QMS) for medical devicesGMP, GDP principles and basic regulatory frameworksMedical device Quality System Regulations (21 CFR 820), ISO 13485, MDD (beneficial)Risk management, risk assessments and documentation updatesNonconformance (NCE), CAPA, SCAR, MRB processesInspection, testing and validation methods for products and processesStatistical analysis and scientific method (beneficial)Basic understanding of microbiology, molecular biology, biochemistry, chemistry, or related fields (beneficial)Nucleic acid amplification and detection technologies (beneficial)Company quality system requirements and standardsSkillsStrong computer literacy: word processing, spreadsheets, databasesAbility to develop and implement procedures, inspection procedures and test methodsExcellent technical writing; able to produce clear quality reports and detailed proceduresAbility to read, analyze and interpret technical procedures, standards, journals and regulationsEffective presentation and communication skillsGood interpersonal skills; able to work with all levels, including in potentially adversarial situationsFamiliarity with Oracle and Agile systems (beneficial)Certified Quality Engineer (beneficial)BehaviorsModels and champions quality values and best practicesActs with urgency in identifying and resolving quality issuesUses sound judgment within defined procedures and practicesFocuses on defect prevention, reduction of variation and waste, and continuous improvementMaintains productive internal and external working relationshipsStays current with industry and technical developments through literature reviewWorks independently on routine tasks, seeking guidance for new or complex assignmentsEngages proactively in cross-functional forums (MRB, NCE, CAPA, SCAR) and regulatory interactionsExperience2–5 years with Bachelor’s degree; 1–2 years with Bachelor’s in a technical field; 0–2 years with a Master’s degreeWorking in regulated environments, ideally FDA‑regulated or medical devices (beneficial)Supporting Operations, Engineering and R&D in product and process developmentParticipating in audits and inspections (facility, supplier, Notified Body, FDA)Handling nonconformances, complaints, root cause analysis and corrective actionsReviewing and approving ECOs, product changes, verification/validation and sustaining engineering documentationWhy join Hologic?We are committed to making Hologic the destination for top talent. 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.The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.Agency and Third-Party Recruiter NoticeAgencies 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.Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.