Quality Assurance - Design

  • Location
    Ottawa, Ontario
  • Job type
  • Category
    Engineering - Quality

Adecco is currently hiring a full-time Quality Assurance - Design for our Medical Manufacturing client in Ottawa West. This is a 1-year contract opportunity offering full time hours, Monday to Friday. The salary for this position will be determined based on education and experience.

Quality Assurance - Design Responsibilities: 

  • Primary on-market quality assurance support for design control activities.
  • Provide guidance and direction to a multi-disciplinary personnel involved in product development and production to arrive at solutions that support the company business objectives and quality standards.
  • Able to define document requirements for products, process and test methods verifications and validations in accordance with FDA QSR’s and specific Design Control projects activities.
  • Understanding of process, design and product/design verification/validation.
  • Able to relate information to specification, product claims and design.
  • Uses clinical knowledge, understanding of competitor’s products, and extrapolation from limited data to assure fitness for use.
  • Contributes to the design, development and implementation of comprehensive product assurance plans providing feedback and corrective action for engineering, manufacturing, service and field operations and supplier’s performance.
  • Liaises with project and program team members on technical and quality matters.
  • Able to collect analyze and interpret data will be an integral part of the daily responsibilities.
  • Able to utilize data to make driven decision and recommendations.
  • Responsible for review and approval of elements of Design Control including but not limited to:  Planning, Device History File(s), Change Control and associated and supporting documentation.
  • May have responsibilities for review and approval of DMF, DMR, MVP, and FMEA.
  • Ensures that quality and compliance to site procedures are communicated and implemented.
  • Quality Assurance - Design Requirements:

  • B.Sc. in science or engineering.
  • 6-10 years of general work experience
  • 4-6 years of Quality Assurance experience in medical device manufacturing or pharmaceutical industries.
  • Design Control Experience is required.
  • Knowledge of Process Validation is an asset
  • Membership on the American Society of Quality Control (ASQ) or Society of Reliability Engineers is an asset.
  • Good knowledge of quality regulations and standards, statistical calculation and measurement and manufacturing processes.
  • Strong knowledge of inspection methods in design, fabrication and production of electronic equipment. Demonstrated skill in using test and measuring equipment. Working knowledge of GMP, ISO standards, FDA regulations, and Health Canada.
  • Superior analytical and problem solving skills and statistical applications experience.
  • Ability to be creativity in achieving objectives while assuring compliance to internal and external requirements.
  • Proven organizational and leadership skills. 
  • Ability to work under pressure in a fast paced environment.
  • Excellent oral and written communication skills and ability to interact effectively with all levels in the organization.
  • If you are interested in the position of Quality Assurance - Design  in Ottawa, please click “APPLY NOW”.


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    Reference number CA_EN_1_021956_1438000

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