|Application Deadline||February 28, 2021|
|Experience Required||4 years|
|Job Duration||1 year|
Primary Responsibilities include:
Primary on-market quality assurance support for design control activities.
Able to define document requirements for products, process and test methods verifications and validations in accordance with FDA QSRs and specific Design Control projects activities.
Understanding of process, design and product/design verification/validation
Responsible for implementation of design control policies and procedures.
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 suppliers performance
Liaises with project and program team members on technical and quality matters
Provide and / or participate in Design Control training.
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
As the ideal candidate for our team you will bring the following education, experiences, knowledge, and skills to the position:
B.Sc. in science or engineering
4-6 years of Quality Assurance experience in medical device manufacturing or pharmaceutical industries.
Design Control Experience is required.
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
If you are interested in this role, please contact
Only those who are qualified for the role will be contacted