Quality Systems Engineer
As a leader in the medical device field, our client designs and
manufactures state-of-the art products for OEMs as well as for their own
portfolio. The environment is fast-paced and offers multiple opportunities for
leadership and career growth.
In this role, you will
contribute to the development of new products and sustaining product
development activities with a focus on Manufacturing Quality and Compliance in
their local facilities.
- Review and report performance of
the quality management system including key process indicators (KPIs)
in and represent Quality Assurance in document and data control, quality
planning, training, product recalls / advisory notices incoming and final
inspection and lead equipment calibration
in vendor selection, approval/qualification and monitoring processes.
Follow- up on supplier issues, including notifications, corrective actions
and supplier audits. Maintain supplier files.
- Review and
disposition non-conforming material, lead and facilitate MRB board
analysis, support, follow-up, effectiveness verification and close out of
- Support creation of technical
files and sign-off for relevant documentation
- Participate in product design
control activities for new and sustaining product development efforts,
including documentation review and changes via formal change control.
- Support risk
analysis activities, including hazard analyses, design and process FMEAs
Process/Design Validation/Verification activities, including software
validation and IQ/OQ/PQ activities
Engineering in the creation, review and approval of DMR, DHR, routers,
bills of material, and specifications for in- house/ external
Internal Audits of the Quality System
- Prepare for
and participate in audits by external organizations, such as FDA, ISO etc.
degree in scientific, biomedical, or engineering discipline
- 5 years
minimum of experience in Medical Device Quality Assurance
performing internal quality audits and supplier audits to ISO 13485
understanding of applicable regulations, including FDA 21 CFR Part 820,
ISO 13485, Health Canada MDD’s, European MDR’s
with single-use and reusable medical devices manufactured in a Class 7
controlled manufacturing environment and electro-mechanical devices