Inginaire - Engineering Staffing

Quality Assurance Engineer

Location
St Paul, MN
Salary
Contact For Rate
Posted
Jul 10, 2018
Closes
Jul 26, 2018
Ref
815873-03
Category
Engineering
Job Type
Employee
Employment Status
Full Time
Inginaire is currently looking for a Quality Assurance Engineer to work for our client in St. Paul, MN. Our client has been committed to the design and manufacture of the highest quality surgical instrumentation and they continue their dedication in providing the best surgical products to medical professionals around the world. Duties

  • Evaluate new product quotes from Quality Assurance standpoint to ensure to all quality activities required to integrate new product into production are defined.
  • Work with manufacturing engineering to develop the quality plan and execute validation activities required to release product for shipment.
  • Ensure validations are fully documented and records are maintained in accordance with GMPs and the company's quality management system.
  • Develop detail inspection procedures and techniques for all new components and/or assemblies to ensure compliance to specifications.
  • Define sampling requirements using sound statistical methods.
  • Work with purchasing and engineering to determine supplier qualification activities based on risk analysis, regulatory and customer requirements.
  • Participate in supplier selection and component specification reviews to ensure suppliers capability to meet requirement.
  • Responsible for notifying suppliers of MRB decisions including issuing of CAR's.
  • Perform receiving inspection and documentation of all production materials, supplies and RGA's.
  • Collect and maintain receiving inspections metrics for supplier scorecard.
  • Participate in corrective and preventive Supports CAPA activities, nonconformance (NCMR) and compliant investigations.
  • Ensure questionable items are placed in quarantine, labeled appropriately, documented, and processed via MRB in a timely manner.
  • Perform trend analysis and provide
  • management with regular reports.
  • Develop validation protocols as required to demonstrate conformance to specifications.
  • Perform validation studies, collect the data and document the results.
  • Ensure validations are fully documented and records are maintained in accordance with GMP's and the company's quality management system.
  • Establish process control limits and trend analysis to ensure processes remains in control.
  • Perform clean room environmental testing and monitoring activities as directed by the Lead QA Engineer.
  • Manage all sterilized loads to the Sterilization Validation Protocol including load size, biological indicators, and LAL samples as required.
  • Assist Lead QA Engineer with final product releases.
  • Work with Lead QA Engineer by providing inspection assistance in CEA or Boxing areas when required by activity levels.
  • Assist with the MRB process by working with area inspection on clearing MRB immediately, maintaining a list/awareness (real-time) of any items in MRB anywhere, maintaining a real-time list of warehouse/receiving/RGA MRB items.

Requirements

  • Bachelor’s degree in engineering discipline and/or equivalent is required.
  • 5-7 years of experience as a Quality Engineer working in a medical device/pharmaceutical manufacturing environment required.
  • Experience with application of ISO 14971 for process FMEA and process validations (IQ/OQ/PQ) to mitigate risks required.
  • Certified Quality Engineer (CQE) or equivalent RA/QA certification in the area of regulated healthcare products is preferred.
  • Statistical Process Control (SPC) and Lean Six Sigma training is preferred.
  • Experience in regulated FDA/GLP/GMP and ISO 13485 quality management systems required.
  • Experience providing technical reports, analysis and documentation using Microsoft Office and analytical software such as Minitab required.
  • Demonstrated ability to identify problems, research solutions and implement improvements required.
  • Excellent hand/eye coordination and specific vision abilities required including color vision, close vision and ability to see fine details under magnification.
  • Advance inspection techniques using measurement instruments such as gauges, micrometers, calipers, indicators, comparators, microscopes and smartscopes.
  • Ability to pay attention to detail to provide precise and accurate measurements, documents and quality records.
  • Heightened ability of manual dexterity preferred.

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