Senior Quality Inspector, Manufacturing

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 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)

Location:th Ave North Plymouth MN

• 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.

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.

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