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Sr. Quality Engineer - Medical Device
ISO 13485 medical device experience required
High mix product experience
About Our Client
Our client is a consumer goods organization that has multiple product lines out to market. They have a very good reputation of treating their employees well and fostering a community of comradeship. Opportunities for growth are prevalent within the organization.
The Sr. Quality Engineer - Medical Device will have responsibilities that include:
- Develop and maintain a quality management system to be compliant with ISO 13485 for an organization that designs, manufactures and distributes medical devices.
- Provide quality engineering support to manufacturing scale-up activities to ensure that product processes have been developed appropriately and are transferred to manufacturing in accordance with user requirements, plus corporate and regulatory guidelines.
- Work cross-functionally with marketing and engineering on new product development while on various products
- Manage and communicate quality data from multiple sources to assist in the risk management and risk-based decision processes
- Manage the corrective and preventive action (CAPA), management review process, and internal quality audit programs
- Manage Non Conforming Material Reviews and MRB activities
The Successful Applicant
The Sr. Quality Engineer - Medical Device should possess:
- Bachelor's Degree in engineering
- High mix product manufacturing experience
- Medical Device, ISO 13485 experience
What's on Offer
- Great work environment
- Top benefits
- Competitive compensation