Job Description

Position Summary:

The Quality Inspector is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards.

Quality Inspectors support manufacturing and servicing operations by performing incoming component and in-process product inspections using standard measurement equipment. They identify, segregate and document rejected material and participate in Material Review Boards to ensure the proper documentation and disposition. They may also review other related Quality documentation such as device history or calibration records.

HOURS: 11am - 7:30pm Monday through Friday

PAY: $18.90 - $22.50hr & bonus

What You'll Do:

• Identifiy, segregate and document rejected components and materials.
• Participate on a Material Review Board (MRB) to review and process non-conformance reports.
• Support NC disposition activities such as re-inspection.
• Enter and retrieve inspection and NC data from local and global systems.
• Review related Quality documentation such as DHR’s or calibration records.
• Support local problem solving activities and may identify opportunities for improvement.
• Complete other duties as assigned.

Skills, Abilities, and Experience:

Reqired:

• High School Diploma or GED Equivilant.

• Ability to work in a fast-paced environment with strict deadlines.- generate detailed, high-quality documentation.

  • work with others in analyzing and solving technical problems.
  • perform / manage multiple tasks in parallel.

• PC experience and working familiarity of common desktop applications including Excel and Word.

Preferred:

• Previous quality expereince working in an ISO, FDA, or similar regulated industry.
• Experience working in Oracle systems.
• Certified Quality Inspector Certification.
• Experience assuring adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and/or similar regulatory fields.

Other:

• Lifting, Pushing, Pulling 25-50lbs.
• Bending, Walking, Standing, Sitting, Typring, Hand Manipulation, Visual Acuity.
• Collaborates with others. Works in a professional manner to support team actions.
• Effectively manages work tasks.
• Is detail oriented and strives for continuous improvement.

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

You should be proficient in:

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