Quality Specialist

Quality Specialist JD

Position Summary

The 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.

What You'll Do

Document Control

Complete document control transactions and manage controlled documents, including formula cards, manufacturing instructions, and product specifications

Manage record retention practices within the site

Flag technical errors or open questions in chemical manufacturing documents

Product Release

Review DHRs and support batch record release for GMP/GDP compliance

Review third-party vendor paperwork and make release decisions based on documentation

Facilitate CAPA and NCR investigations and coordinate investigation documentation

Support site inspection and calibration recordkeeping

Broader Quality Support

Manage Customer complaint investigations and complete complaint documentation

Coordinate internal and external audits

Support supplier quality and Customer assessment activities

Track and trend site Quality data, support Management Review

Support targeted Lean activities

Complete other duties as assigned

Experience, Skills, and Abilities

Required

Associate's degree and 2 years of experience in Quality in a regulated industry (FDA/ISO 13485 or similar), OR

High school diploma/GED and 6 years of experience in a regulated industry

Preferred

Experience 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 role

Windchill PLM experience is a strong plus; STERIS has run on Windchill for over 20 years. Not required to start, but a faster ramp

Oracle 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 in

MS Office proficiency, especially Word, Excel, and Access

Prior Customer support experience, including responding to complaints or documentation requests

Familiarity with lab paperwork or test results is a bonus, not required

Other

Customer Focused: responds with a sense of urgency and keeps the customer's needs central

Teamwork: collaborates well across lab, manufacturing, and quality engineering

Results: manages multiple workstreams at once, detail-oriented, comfortable analyzing technical documents and adapting to shifting priorities

Communication: writes clearly, keeps manager and coworkers informed

Job Knowledge: comfortable with common desktop applications; light technical background helpful for reading chemical manufacturing documents

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