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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