Quality Specialist 3

Job-ID: 12531Category: Quality & Regulatory AffairsLocation: Marlborough, MA, United StatesSchedule: Full timePosted: 2026-10-27We are looking for senior-level QMS Specialist responsible for serving as a CAPA, Nonconformance, and Quality Compliance SME to drive compliant, sustainable QMS improvements, support remediation and inspection readiness, and partner cross-functionally across regulated medical device quality system workstreams.KnowledgeQuality Management System (QMS) requirements in a regulated medical device environmentCAPA, Nonconformance (NC), and quality compliance processes, methodologies, and best practicesFDA 21 CFR 820 / QMSR, ISO 13485, ISO 14971, EU MDR, MDSAP, and other applicable global regulatory standardsRoot cause analysis, risk assessment, corrective actions, containment, disposition, and effectiveness checksInternal audits, external audits, change control, management review, and quality data trendingAudit and inspection readiness, including FDA inspections, Notified Body audits, MDSAP audits, and internal auditsQuality metrics, dashboards, reporting tools, and data-driven continuous improvementStatistics and statistical analysis, preferredProduct Lifecycle Management systems such as Agile, preferredReporting systems such as Qlik, PowerBI, or equivalent toolsSkillsAbility to serve as a Subject Matter Expert for CAPA, NC, and quality compliance processesStrong root cause analysis, risk assessment, problem-solving, and analytical skillsAbility to lead or support remediation of QMS processes, procedures, and recordsStrong technical writing skills for regulatory documentation, investigations, CAPAs, NCs, and quality recordsAbility to develop sustainable corrective actions and effectiveness checksAbility to manage dashboards, metrics, reports, and quality performance trackingStrong written and verbal communication skills, including executive-level updatesAbility to present information to director-level leadershipAbility to lead cross-functional teams and manage multiple workstreamsAbility to train, coach, and mentor junior staff and cross-functional teamsStrong organization and program management skillsBehaviorHands-on, accountable individual contributor with SME-level ownershipDetail-oriented with a strong focus on compliance, effectiveness, sustainability, and qualityProactive in identifying gaps, trends, systemic risks, and process improvement opportunitiesCollaborative and able to partner effectively across functions, sites, and divisionsComfortable advising teams on complex or systemic quality issuesAdaptable and able to operate in high-visibility, fast-paced environmentsStrong escalation judgment for CAPA, NC, and compliance issuesContinuous improvement mindsetAble to coach others and promote process adherence and regulatory expectationsExperience2–5 years of Quality Systems experience with a technical bachelor’s degree, or 1–3 years with a master’s degreeExperience in a regulated industry, preferably medical devicesExperience managing or working with CAPA, NC, and other QMS processes across multiple sitesExperience supporting QMS compliance workstreams, including CAPA, NC, audits, change control, and quality data trendingExperience supporting remediation activities in response to audit findings, inspection observations, enforcement actions, or continuous improvement initiativesExperience preparing for or supporting FDA inspections, Notified Body/MDSAP audits, and internal auditsExperience working cross-functionally with process owners, CAPA/NC owners, remediation leads, and quality teamsExperience using Agile or equivalent PLM systemsExperience using Qlik, PowerBI, or other metric reporting systemsAbility to travel up to 15%, including potential international travelWhy 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 $85,200 - $133,300 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.#LI-NK1