Quality Specialist

Quality SpecialistThe Quality Specialist supports quality functions at STERIS's site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. The role splits into two main functions: document control and product release.This is a desk-based position with no lab work required, though familiarity with lab paperwork is a plus. The Quality Specialist works closely with lab, manufacturing, and quality engineering teams, primarily by phone, to keep controlled documents accurate and to review batch records and vendor paperwork for release decisions. The role also supports Customer complaint investigations, audit coordination, supplier quality and customer assessments, risk management activities, and site Quality data tracking.This is an onsite position.Document ControlComplete document control transactions and manage controlled documents, including formula cards, manufacturing instructions, and product specificationsManage record retention practices within the siteFlag technical errors or open questions in chemical manufacturing documentsProduct ReleaseReview DHRs and support batch record release for GMP/GDP complianceReview third-party vendor paperwork and make release decisions based on documentationFacilitate CAPA and NCR investigations and coordinate investigation documentationSupport site inspection and calibration recordkeepingBroader Quality SupportManage Customer complaint investigations and complete complaint documentationCoordinate internal and external auditsSupport supplier quality and Customer assessment activitiesTrack and trend site Quality data, support Management ReviewSupport targeted Lean activitiesComplete other duties as assignedExperience, Skills, and AbilitiesRequiredAssociate's degree and 2 years of experience in Quality in a regulated industry (FDA/ISO 13485 or similar), ORHigh school diploma/GED and 6 years of experience in a regulated industryPreferredExperience with document control, change control, or product release/batch record review in a regulated environment (pharma, medical device, or chemical manufacturing)Experience managing multiple concurrent projects with shifting or compressed timelines — this is one of the strongest signals of fit for this roleWindchill PLM experience is a strong plus; STERIS has run on Windchill for over 20 years. Not required to start, but a faster rampOracle ERP experience is a bonus, not a requirement — STERIS went live on Oracle in April 2026 and the team is still ramping, so training is built inMS Office proficiency, especially Word, Excel, and AccessPrior Customer support experience, including responding to complaints or documentation requestsFamiliarity with lab paperwork or test results is a bonus, not requiredOtherCustomer Focused: responds with a sense of urgency and keeps the customer's needs centralTeamwork: collaborates well across lab, manufacturing, and quality engineeringResults: manages multiple workstreams at once, detail-oriented, comfortable analyzing technical documents and adapting to shifting prioritiesCommunication: writes clearly, keeps manager and coworkers informedJob Knowledge: comfortable with common desktop applications; light technical background helpful for reading chemical manufacturing documents