Senior Regulatory Quality Inspector -- Medical Devices

Job Description

Job Description

Day in the Life

Your day begins at 6:00am. With drawings in hand and CMM, calipers, drop gauges, and micrometers at the ready, you verify complex incoming components and in‑process assemblies against ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR requirements. You capture measurements, compare them to specifications and GD&T callouts, and document findings with precision. When something is off, you don’t just flag it—you dive into root cause, collaborate with Operations, and help drive countermeasures that prevent recurrence.

As the morning progresses, you may review Device History Records for completeness, support site calibration and environmental monitoring, and sit on the Material Review Board to disposition non‑conformances. Throughout the day, you trend key quality metrics for your area, support creation of incoming inspection plans, and keep meticulous records that stand up to regulatory scrutiny.

Schedule

6:00am – 2:30pm, Monday through Friday

What You’ll Do

• Perform advanced incoming component and in‑process inspections using sophisticated measurement systems.
• Lead and participate in quality investigations and structured problem‑solving/root‑cause activities.
• Support development of incoming inspection plans and criteria.
• Identify, document, and communicate product and process non‑conformances.
• Spot and propose opportunities for continuous improvement.
• Participate on the Material Review Board to review and process non‑conformance reports.
• Review DHRs for accuracy and completeness against standards.
• Track, trend, and report quality data for assigned processes and areas.
• Support site calibration and environmental monitoring as needed.
• Perform additional duties as assigned.

What You BringRequired

• High School Diploma or GED.
• Proficiency reading engineering drawings, interpreting GD&T symbols, and checking dimensions/tolerances on raw materials.
• Ability to understand and follow written and verbal work instructions/SOPs and safety labels.
• 3+ years in mechanical inspection or other technical production work.
• PC skills with common desktop apps, including Excel and Word.
• Comfort working in a fast‑paced environment with strict deadlines.
• Strong documentation skills with high attention to detail.
• Collaborative approach to analyzing and resolving technical problems.

Preferred

• Basic knowledge of GD&T.
• ERP experience (SAP, Windchill, Trackwise, etc.).
• Experience in regulated environments adhering to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR.
• Hands‑on experience with measurement equipment: Calipers, Drop Gauges, Micrometers, etc.
• Expert ability to read and comprehend complex specifications and SOPs.
• Prior Quality Inspector experience in medical device manufacturing or related industries.

Other

• Ability to manage multiple tasks in parallel.
• Professional collaboration skills to support cross‑functional actions.
• Detail focus with a continuous improvement mindset.
• Ability to lift, push, and/or pull 25–50 lbs.
• Temperature‑controlled warehouse environment.

Tools & Technologies

• Coordinate Measuring Machine (CMM)
• Calipers and Micrometers

Proficiencies

• ISO 13485
• FDA Regulations
• ISO 9001 Certification Experience

What STERIS Offers

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well‑being, and financial future. Here is just a brief overview of what we offer:

• Market Competitive Pay
• Extensive Paid Time Off and (9) added holidays
• Excellent Healthcare, Dental and Vision Benefits
• Long/Short Term disability coverage
• 401(k) with company match
• Maternity & Paternal Leave
• Additional add‑on benefits/discounts for programs such as Pet Insurance
• Tuition Reimbursement and continued educations programs
• Excellent opportunities for advancement and stable long‑term career