Medical Device Quality Control Inspector

Step into a Day in the Life

At STERIS, you’ll join a team dedicated to safeguarding patients and customers through uncompromising quality. As a Medical Device Quality Control Inspector, you will be a key partner to manufacturing and service operations by verifying that components and products meet stringent standards such as ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, and EU MDR.

Your Typical Shift (11:00 AM – 7:30 PM, Monday–Friday)

• 11:00 AM: Review the inspection queue and prioritize incoming component lots. Set up standard measurement tools (e.g., calipers, micrometers, gauges) to perform acceptance checks.
• 12:30 PM: Log results and nonconformances, entering and retrieving inspection and NC data in local and global systems. Ensure traceability and accuracy in records.
• 1:30 PM: Conduct in-process inspections on the production floor, verifying product characteristics at key control points and supporting production teams in a fast-paced environment.
• 3:00 PM: Participate in the Material Review Board (MRB) to review and process nonconformance reports, support disposition decisions, and coordinate re-inspection when needed.
• 4:30 PM: Review quality documentation such as Device History Records (DHRs) and calibration records for completeness and compliance.
• 6:00 PM: Support local problem-solving activities, contribute ideas for continuous improvement, and complete other duties as assigned.

Core Responsibilities

• Perform incoming and in-process product inspections using standard measurement equipment.
• Identify, segregate, and document rejected components and materials with clear disposition status.
• Participate in MRB activities and assist with NC dispositions, including re-inspection.
• Enter and retrieve inspection and NC data from local/global systems to maintain robust quality records.
• Review related Quality documentation, including DHRs and calibration records.
• Support problem solving and continuous improvement initiatives across the site.
• Ensure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and related regulatory requirements.

Schedule & Pay

Hours: 11:00 AM – 7:30 PM, Monday–Friday

Pay: $18.90 – $22.50 per hour + bonus

What You Bring

• High School Diploma or GED equivalent.
• Ability to thrive in a deadline-driven setting, produce detailed and high-quality documentation, collaborate on technical problem-solving, and manage multiple tasks simultaneously.
• PC literacy with Excel and Word.

Preferred

• Quality experience in ISO-, FDA-, or similarly regulated industries.
• Exposure to Oracle systems.
• ASQ Certified Quality Inspector (CQI) or similar credential.
• Experience supporting compliance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, or comparable standards.

Physical & Workstyle Expectations

• Lifting, pushing, and pulling 25–50 lbs.
• Regular bending, walking, standing, sitting, typing, hand manipulation, and visual acuity.
• Team-oriented collaborator with strong task management skills, attention to detail, and a continuous improvement mindset.

Benefits at STERIS

We invest in your health, well-being, and future with a comprehensive total rewards package:

• Market competitive pay
• Extensive paid time off plus nine additional holidays
• Medical, dental, and vision coverage
• Short- and long-term disability
• 401(k) with company match
• Maternity and paternal leave
• Optional add-ons and discounts (e.g., Pet Insurance)
• Tuition reimbursement and continuing education programs
• Excellent advancement opportunities and long-term career stability

Proficiencies

• Quality Inspection Experience
• ISO 13485
• FDA Regulations
• ISO 9001 Certification Experience
• Chemical Manufacturing
• Manufacturing
• Production Line
• Quality
• QMS

Join STERIS and help us maintain the highest standards of product quality and patient safety.