ICU Medical-posted 3 months ago
Southington, CT
Merchant Wholesalers, Durable Goods

The Sr. QA Inspector performs testing and inspection of sub-assemblies, final product, commodities, GMP, BOP, safety compliance audits. The Sr. QA Inspector enforces GMP compliance as outlined in internal BOPs. The individual is primarily responsible for testing, inspection and release of product and product components and commodities. The individual records and reports results to provide information necessary to assure that product has been manufactured in accordance with established quality standards.

  • Initiate change requests, BOPs, EPWOs, deviations, NCMRs
  • Close-out audit work orders and commodity release
  • Complete product and part inspection
  • Complete sample pulling
  • Complete labeling inspection and control
  • Provide line clearance approval
  • Monitor GMP practice
  • Quarantine and release quarantined materials
  • Train new employees and team on GMP and BOPs
  • Perform defect tracking, monthly reporting and data entry
  • Complete test requests
  • Ensure departmental compliance to all Federal, State, Local and Company regulatory requirements
  • Perform these and other duties as necessary or required
  • Work on special projects as they arise
  • Actively demonstrate support through interactions with solid communication skills, attitude, dedication, commitment, respect, pride and trust
  • Must be 18 years of age
  • High School Diploma or GED required
  • One year previous experience as an MQA or QA Inspector preferred
  • Experience with medical devices/pharmaceutical GMPs preferred
  • Excellent Mathematical knowledge
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