Senior Quality Inspector
About The Position
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. 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
Requirements
- Highschool Diploma or G.E.D. Equivalent.
- Ability to read engineering drawings (specifications), interpret lines and GD&T symbols, and check dimensions and tolerances on raw materials.
- Ability to read, understand, and follow verbal and written work instructions/SOPs and safety warnings labels.
- 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
- Ability to generate detailed, high-quality documentation.
- Ability to work with others in analyzing and solving technical problems.
- Ability to lift, push, and/or pull 25-50lbs.
Nice To Haves
- Basic knowledge of GD&T (Geometric Dimensioning and Tolerancing).
- Previous experience working in ERP (Enterprise Resource Planning) Systems. Specifically: SAP, Windchill, and/or Trackwise, etc.
- Experience working in a regulated environment having to adhere 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 specifications and S.O.P.s.
- Previous experience working in as a Quality Inspector in the medical device manufacturing or related industries.
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
