As an engineer with significant experience in the medical device industry and a true commitment to quality in the work you do and the products you help create this is a role that you should seriously consider! Joining means that you have aligned yourself and your career with an industry leader, and be a part of a high performing team. Your primary role will be to support the maintenance of quality system requirements, including: CAPA system, external, internal and supplier audits, quality metrics reporting, management review preparation, and training.
The work can be challenging and at the same time rewarding. It could well be the reason you became an engineer and chose to be involved in the medical device industry.
In this job, you will:
- Establish and update quality system procedures in compliance with requirements for medical devices
- Be process owner for corrective and preventive action system (CAPA)
- Plan and conduct quality system audits in accordance with documented procedures
- Support/manage external audits and regulatory inspections
- Participate on Material Review Board to oversee non-conformance investigations and help implement corrective actions.
- Prepare metrics in support of trending and management review
- Support Quality Assurance, Quality Control, and Regulatory functions as necessary
- Bachelor's degree (B.S.) from a four-year college or university or related experience
- Have a minimum of 3 years of experience in Quality within a medical device company (electronic medical device experience a plus)
- Have experience working with the following regulations: The Food and Drug Administration’s Quality System Regulations (FDA QSRs), International standards such as ISO 13485, ISO 14971, Medical Devices Directive (MDD), and Canadian Medical Device Regulations (CMDR).
- Experience with statistical analysis of quality data
- Direct experience managing or participating in an FDA and other agency audits a very real plus
- CQA or other ASQ certification a plus