Senior Quality Inspector, Manufacturing

Position Summary:

The Senior 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. The Senior Quality Inspector supports manufacturing and servicing operations by performing incoming component and in-process product inspections which are more complex requiring the use of sophisticated measurement systems and instrumentation. Senior Quality Inspectors identify and document component, process and product non-conformances and lead investigation/root-cause countermeasure activities. They work with operations team members to perform and document problem-solving investigations. In addition, Senior Quality Inspectors may oversee device history record reviews and manage calibration and environmental monitoring processes.

Hours: 6am - 2:30pm Monday through Friday + overtime as needed

*Training hours will be 8am - 4:30pm

Pay: $22 - 27hr + overtime (as needed) & quarterly bonus

Location: 14605 28th Ave North Plymouth, MN

What You'll Do:

• Conduct complex incoming component and in-process product inspections.
• Participate in quality investigations and associated problem-solving/root-cause activities.
• Support the creation of incoming inspection plans.
• Identify and document product and process non-conformances.
• Identify opportunity for process continuous improvement.
• Participate on a Material Review Board to review and process non conformance reports.
• May review DHR paperwork for completeness and accuracy against standards.
• Track, trends and reports quality data for assigned areas.
• May support site calibration activities depending on facility structure.
• Complete other duties as assigned.

Skills, Abilities, and Experience:

Required:

• Highschool Diploma or G.E.D. Equivalent.
• Minimum of three (3) years of experience in mechanical inspection or other technical production tasks.
• PC experience and working familiarity of common desktop applications including Excel and Word.
• 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.
  • read, understand, and follow verbal and written work instructions/SOPs* and safety warnings labels.
    • *engineering drawings (specifications), interpret lines and GD&T symbols, and check dimensions and tolerances on raw materials.

Preferred:

• Strong knowledge of GD&T (Geometric Dimensioning and Tolerancing).
• Previous experience working in ERP (Enterprise Resource Planning) Systems like: SAP, Windchill, and/or Trackwise, etc.
• Experience working in a regulated environment requiring adherence with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR regulations.
• Previous expereince using measurement equipment like: Calipers, Drop Gauges, Micrometers, etc.
• Expert ability to read and comprehend complex engineering specifications and S.O.P.s.
• Previous experience working in as a Quality Inspector in the medical device manufacturing or related industries.
• Continuous Improvement (C.I.) and/or Process Improvement (P.I.) expereince in a Quality setting.
• Expereince writing and updating S.O.P.s in adherence to Good Documentation Practices (GDP).

Other:

• Ability to perform/manage multiple tasks in parallel.
• Ability to collaborate with others and work in a professional manner to support team actions.
• Effectively manage work tasks with attention to detail while striving for continuous improvement.
• Ability to lift, push, and/or pull 25-50lbs.
• Working in a warehouse environment - area may be hot/cold due to dock doors.

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

Pay range for this opportunity is $22.47 - $29.08. This position is eligible for bonus participation.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits

Open until position is filled.

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit

If you need assistance completing the application process, please call View phone number on click.appcast.io. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location's HR Office during normal business hours.