|Job Category||Professional Consulting|
|Application Deadline||January 31, 2021|
|Experience Required||5+ years|
|Job Duration||1 year|
Primary Responsibilities include:
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 QSRs 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 competitors products, and extrapolation from limited data to assure fitness for use.
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.
Able to collect analyze and interpret data will be an integral part of the daily responsibilities.
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.
Ensures that quality and compliance to site procedures are communicated and implemented.
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.
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.
If you are interested in this role, please contact
Only those who are qualified for the role will be contacted