Quality Assurance Engineer

  • Category
    Engineering
  • Location
    , Massachusetts
  • Type
    Direct hire
Quality Assurance Engineer - Medical Device 
Middlesex County, MA

(Local candidates only/must be a US Citizen or Green Card Holder)

The Quality Assurance Engineer will be directly responsible for the continued maintenance and further development of the Quality Management System and quality improvement activities and opportunities as it relates to inspection, manufacturing testing, and support of released products including medical instrumentation and chemical solutions.

A BS in Chemistry, Biomedical, Electrical, Mechanical, or Industrial Engineering is required.  The ideal candidate will meet the following criteria:
 

  • Minimum of 5 years Quality/Engineering experience
  • Direct FDA GMP and ISO 13845 Quality System experience
  • Medical Device or analytical laboratory, chemical/reagents manufacturing or support experience
  • Applied knowledge of quality and statistical tools such as Six Sigma, Lean Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R
  • Applied knowledge of FDA and international medical device regulations
  • Possess Excellent Microsoft skills including Excel
The QA Engineer's Duties and Responsibilities will include:
  • Oversee the Quality Assurance Laboratory including the preparation of chemical solutions, value assignment activities, lot qualifications and investigations on non-conformances.
  • Oversee Quality Control activities in manufacturing to ensure product conformance to specifications
  • Perform trend analysis and report on product and process yields, customer complaints, CAPAs, nonconforming material, and cost of quality related issues
  • Drive continuous improvement program engaging cross-functional teams by investigating, developing and facilitating process yield, product, cost reduction and documentation improvement plans
  • Initiate corrective and preventive action activity, lead and support CAPA investigations and monitor effectiveness
  • Support Quality Assurance with Management Review and Quality Meeting planning and reporting materials
  • Review existing Quality System documentation for accuracy and relevancy
  • Develop, update and maintain Quality System procedures, work instructions, flowcharts, forms, checklists and worksheets
  • Perform testing and qualification of chemistry lots and associated production materials and activities
  • Review new product releases and assist with the transfer to Manufacturing
  • Support Quality and Purchasing with vendor selection, qualification and performance reporting.
  • Monitor vendor performance, work with vendors requiring further development and resolving MRB vendor- related discrepant material problems
  • Monitor and report on investigative activities related to customer returned materials
  • Support and verify calibration, update and maintenance of equipment, fixtures and test stations.
  • Support internal and external quality audits, report on results
  • Verify and assist with training of company personnel as required
  • Ability to work collaboratively with cross  functional teams
  • Have Strong organizational, attention to detail and follow-through skills
  • Demonstrated problem-solving and troubleshooting skills
  • Excellent writing and verbal communication skills

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