Quality Assurance Engineer


Position Summary

To act as a technical and system knowledgeable resource in all matters related to the quality and reliability of company product. To lead development of validation plans, protocols and reports and participate in a hands-on manner regarding all activities involved in the planning, problem resolution, continuous improvement, and conformance verification of the design, procurement and manufacture of company supplied goods and services.

Primary Responsibilities

  • Review & approve drawings, specifications, manufacturing instructions, and bills of material for completeness, accuracy, producibility, and compatibility with existing documentation. Participate in ECO sign-off and approval.
  • Write inspection / test / calibration procedures for equipment and product
  • Perform Risk Management activities (FMEA, Hazard Analysis, etc.)
  • Manage the completion of validation protocols and test plans (IQ, OQ, PQ, test method and inspection method qualification), including the specific performance of compliance testing
  • Collect, analyze, and take action on performance measurement indices, statistical capability / reliability analysis
  • Disposition non-conforming material (NCMR)
  • Lead and/or participate in product complaint investigations leading to root cause
  • Propose, lead, initiate and follow-up on Corrective Action and Preventive Actions (CAPA)
  • Provide technical assistance, training and support to inspection personnel pertaining to electro-mechanical verification techniques and procedures
  • Assist in inspection / test equipment evaluation and selection
  • As appropriate, assist in supplier management (surveys, visits, and supplier corrective action)
  • Other duties as assigned by manager

Desired Skills and Experience

  • Minimum 4-year degree in Engineering or Bio-Medical Engineering
  • 3 to 5 years’ experience as a Quality Engineer in the medical device industry
  • Technical skills including the ability to read technical specifications; utilize measurement tools & equipment
  • QSR and ISO13485 experience required
  • Must have experience in CAPA, NCMR, validation (IQ, OQ, PQ, etc.), DMR, DHR, risk management activities, statistics and design controls
  • Interfaces with all departments in the organization in matters related to the quality system compliance and functional performance of product
  • Effective and professional communication skills; Internal (engineering, operations, R&D, etc.) and external (customers, auditors and suppliers) required
  • Effective written communication skills, with the ability to author clear, concise, and accurate procedures, analyses, protocols and reports
  • Familiarity with electrical component handling and ESD controls
  • Computer literacy (MS Office, Visio, Minitab, etc.) is required
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