Quality Assurance Technician II

St Paul, MN

Inginaire is seeking a Quality Assurance Technician for our client, a designer and manufacturer of surgical instrumentation for clients around the world, located in St. Paul, MN. The Quality Assurance Technician is responsible for performing in-process quality monitoring, inspecting and testing activities, supporting Nonconforming Material Review Board activities, supporting outsourced sterilization and test lab activities, performing medical device/drug batch record review/release, performing receiving inspection of raw materials for device/drug products, collecting and recording data for quality metrics and trend analysis, assisting with investigations and root cause analysis, working with outsourced test labs and suppliers of critical services and materials, and assisting with tasks as needed/requested by supervisor/manager. This is a direct hire opportunity.

Duties

  • Assist with analytical tests required for device/drug products.
  • Support manufacturing with first article inspections and in-process inspection, measurement and test activities (i.e. UV/VIS, Instron Strength Test, Visual Inspection, etc.).
  • Verify that manufacturing activities and products conform to specifications and quality procedures.
  • Verify and reject nonconforming materials for MRB action as required.
  • Document and quarantine nonconforming materials for MRB review.
  • Assist with investigations and corrective actions as required by the MRB.
  • Implement MRB disposition decisions in a timely manner.
  • Maintain accurate MRB logs and records.
  • Assist sales with new customer sterilization and test lab quotations.
  • Assist with sterilization validation activities per customer requirements.
  • Assist with writing sterilization test protocols and manufacturing procedures.
  • Build/verify sterile load configurations per customer requirements, including placement of biological indicators.
  • Ensure sterilized loads are held in quarantine until lab results are reviewed and released by QA.
  • Audit batch records for GMP and GDP compliance.
  • Verify data recorded meets specifications.
  • Identify documentation errors and/or nonconformities.
  • Release batch and issue certificate of conformity.
  • Perform material testing of solids and gases for drug products.
  • Perform receiving QC inspects of components and supplies.
  • Maintain accurate inspection logs and records.
  • Quarantine rejected materials and initiate a nonconforming material report.
  • Inspect returned goods for conformance with specifications.
  • Support supplier corrective actions as authorized by the MRB.
  • Perform quality control tests, measurements and inspections and collect data, (i.e. incoming materials, bioburden, analytical results and process controls).
  • Monitor data for trends, excursions and corrective actions.
  • Assist engineering and analytical associates with gathering data and information in support of Corrective and Preventive Actions and Complaint investigations.
  • Generate test lab submissions and documentation in support of production activities.
  • Prepare samples for shipment to test labs.
  • Assist with the review of test results and data entry.
  • Assist with supplier corrective actions as directed.

Requirements

Education and Experience

  • Technical school degree in Applied Science and/or equivalent (e.g. ASQ certification plus relevant work experience).
  • Minimum 5 years Quality Assurance experience in a GMP medical device/drug manufacturing environment.
  • General knowledge and use of the following standards:
    • ISO 11135 and ISO 11137 for Ethylene Oxide and Gamma sterilization
    • ISO 13485 and FDA CFR 820, 210 and 211 quality system regulations
    • ISO 14644 Cleanrooms and associated controlled environments
  • Basic test lab experience, lab safety and use of test instruments:
    • UV/Vis
    • FTIR
    • Physical test methods (gravimetric, tensile, visual)
  • Review of batch records and release of materials/products
Qualifications
  • Use of inspection, measuring and test equipment
  • Good manual dexterity
  • Good documentation practices and record keeping
  • Computer skills (Excel, Word, Minitab, etc.)
  • Excellent attention to detail

Post Date: 01.30.2019

Salary: Contact for Rate

Shift: 2nd

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If you would prefer to speak directly to an Inginaire Staffing Consultant, please call us at 612-977-1450 and reference OrderID 816361


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Would you like an opportunity to work for some of the most renowned engineering companies in the Midwest? If you have the job skills, a proven work history, and are energized to start something new, our friendly staffing team is eager to guide you through the application and screening process, and make something awesome together. With unique employee benefits, job training programs, zero registration fees, and above-and-beyond personalized service – you’ll wonder why we haven’t partnered sooner! Get in touch with us to get the ball rolling.

Inginaire is an Equal Opportunity Employer.