Senior Quality Inspector, Manufacturing

STERIS•Plymouth, MN

20h•Onsite

About The Position

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.

Requirements

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
Ability to generate detailed, high-quality documentation.
Ability to work with others in analyzing and solving technical problems.
Ability to read, understand, and follow verbal and written work instructions/SOPs and safety warnings labels.
Ability to read engineering drawings (specifications), interpret lines and GD&T symbols, and check dimensions and tolerances on raw materials.

Nice To Haves

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).

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.