We are searching for an experienced Specialist who considers Quality Assurance and Regulatory guidelines a “must have” for all product development projects; someone who enjoys focusing on the daily maintenance and implementation of a Quality Management System (QMS) and contributing to the ongoing improvement of processes in engineering development and manufacturing; an individual who is looking for a special company where creativity, innovation and most-importantly, quality is embraced and celebrated.
The Senior Quality Assurance and Regulatory Affairs Specialist will have the opportunity to deliver customized QMS-in-a-box solutions for our customers, participate in audits, write or review Standard Operating Procedures (SOP) and will manage and drive solutions for Non-Conformance reports, customer complaints and vendor corrective actions. The Specialist will support and manage regulatory submissions for medical devices, review change control documents, and support the project management team throughout each product’s life cycle. It will be critical to effectively communicate with and collaborate with this multi-disciplinary team of senior designers, engineers and physicists.
Our Perfect Candidate:
Reporting to the QA/RA Director, you will bring a minimum of 10 years of work experience in quality assurance and/or regulatory affairs in a Good Manufacturing Practices (GMP) regulated environment, Ideally, you will have a Bachelor Degree in engineering or sciences, and experience in a high-tech industry; management experience is a plus. You have an in-depth understanding of QMS and ISO standards with solid experience in auditing, interpreting and applying regulations and compliance concepts. You understand that collaborative, cross functional teams are the most effective, and your communication skills successfully bring these diverse groups together to spawn creative, open-minded and out-of-the-box thinking.
Please see the full job description to learn about the finer details of this position. Salary will be commensurate with skills and experience, and a benefits and profit sharing package are included.
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About StarFish Medical
Located in near Uptown in beautiful Victoria, BC, StarFish Medical visitors are immediately met with a smile in an open concept office and an environment that is filled with both a sense of driven ...