Quality Inspector II

Job Description

Job Description

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

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.
• 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.

Preferred:

• 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.

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.

• Temperature controlled, warehouse environment.

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:

• ISO 13485
• FDA Regulations
• ISO 9001 Certification Experience

Machines & technologies you'll use:

• Coordinate Measuring Machine (CMM)
• Calipers and Micrometers