ARKRAY USA, Inc.
  • 18-Apr-2017 to 17-Jun-2017 (CST)
  • Operations
  • Edina, MN, USA
  • Hourly
  • Full Time

Medical, Dental, Group Life Insurance, Voluntary Life Insurance, Disability, 401(k) Plan, Flexible Spending Plans, Tuition Reimbursement, Paid Time Off (PTO) and Holiday Pay


Be involved with a company that is changing the lives of people across the globe.

ARKRAY is currently looking to fill a Quality Control Inspector position to perform incoming, in-process, final and returned goods quality control inspection and testing of medical products, as directed by the Quality Control Manager. First Shift: 6:30am-2:30pm

Duties and Responsibilities

 

  • Ability to perform the general Quality Control Inspector activities including but not limited to: ERP System Transactions; 1st Proof/1st Article Inspections; Complete Work Order Packet Releases for Production; Assist with quality studies, and update spreadsheets or databases
  • Supporting QC Receiving Inspection related duties: Create and maintain incoming files; Understand sampling plans ANSI/ASQ Z1.4; Inspection of incoming raw materials, packaging components, distributed product, and kits to ensure materials are within specification and documentation is complete and correct
  • Supporting QC Inspection related duties for In-Process and Final Inspections: Inspection of in-process products ex:  Biosensor test strips, PMI packaging line, meter kits, distributed product;  Finished product inspections (Follow Sampling Plan ANSI/ASQ Z1.4)
  • Complaint Investigations: Review of product batch records and retains for customer complaints; Returns Goods Processing includes Preparation and handling of returned products, perform investigations and diagnostic testing, Order Services Returns processing, RMA verifications, Order Services Returns processing, RMA verifications, maintaining returned product storage and disposal
  • Supporting documentation review of quality records: Initiate document change orders when required; Performs thorough DHR reviews for compliance; Maintenance of documentation and retains in compliance with regulatory requirements (ISO 13485), cGMP's and aid in filing of records

Knowledge and Skills

  • 2+ years Quality Control experience required (Medical Device experience preferred)
  • Knowledge of ISO 13485, QSR 21 CFR Part 820 regulatory requirements as well as understanding of ANSI/ASQ Z1.4 (Sampling Plan)
  • Need to be detail oriented, understand the importance for complete and accurate documentation (cGMP)
  • Ability to read and interpret drawings and specifications
  • Knowledge of measuring equipment used to perform dimensional inspections e.g., caliper, ruler, micrometer, toolmakers scope, vision measuring systems, etc.
  • Must be comfortable with the use of personal computers e.g., Windows based software, Word, Excel, Access and Visual
  • Ability to work independently on projects with little supervision

ARKRAY is an Equal Opportunity Employer: minorities, women, veterans, and individuals with disabilities are encouraged to apply.

ARKRAY USA, Inc.
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