Job Description

We have a new opportunity for a Quality Assurance and Regulatory Affairs Specialist in Victoria, BC. Reporting to the QA/RA Manager, you will be a member of the Quality Assurance/Regulatory Affairs team. You will provide quality assurance and regulatory support to medical device product development and manufacturing departments. The Quality Assurance & Regulatory Specialist will ensure product specifications are met and enforce StarFish Medical\xe2\x80\x99s standard operating procedures (SOPs). This role requires a motivated, self-driven and strong individual contributor. Are you enthusiastic, driven, and pay great attention to detail? Are you passionate about driving and maintaining a culture of quality and helping project teams succeed? Do you have the ability to inspire internal clients to appreciate the importance of quality compliance while also thinking creatively about how to get their buy-in? If this sounds like you and this opportunity sounds intriguing, keep reading! What does StarFish Medical offer you?

• The opportunity to work on cutting-edge technology.
• Award-winning culture with deep-rooted Guiding Principles.
• Competitive compensation.
• Team profit-sharing program.
• Excellent company-paid benefits package.
• Paid vacation and sick leave.
• Monthly All-hands meetings.
• Active social committee.
• 50% BC Transit Cost Sharing.
• The Victoria Office offers shower facilities for midday runs or biking to work, and Galloping Goose access is close by.
• The location also offers free parking on-site or around the premises.

You will:

• Review and may be responsible for authoring SOPs (Standard Operating Procedures) and Work Instructions, with minimal supervision.
• Work closely with personnel to resolve all issues resulting from SOP reviews (document corrections, deviations, and clarifications).
• Participate in internal audits of the Quality Management System, prepare audit reports, and follow up on nonconformances.
• Provide data for preparation of monthly Quality Assurance reports, including quality issues by product, metrics, and summary of any quality problems.
• Participate in developing and delivery of training on quality and regulatory courses as needed.
• Assist with regulatory agency inspections as required.
• Identify manufacturing process issues based on product testing results.
• Monitor the effectiveness of product Quality testing, including documentation of final test results, review and approval of Device History Records (DHRs) and product release, and provide input on decisions to approve/reject (Engineering Change Requests) ECRs.
• Communicate with internal groups at Starfish Medical and clients to resolve quality issues to support batch release and disposition.
• Support Supplier Qualification and Evaluation Activities.

This is an abridged version of the responsibilities; kindly review the full (StarFish Medical Career Portal)to understand the full scope of duties. Our ideal candidate for this role brings the following:

• Post-secondary education, preferably in a technical or science field with a minimum of 3 years of work experience in a quality assurance and/or regulatory affairs role in a GMP (Good Manufacturing Process) regulated environment, preferably medical devices or an equivalent combination of education and experience.
• Lead ISO 13485 Auditor, ASQ, SQA or RAPs certification desirable.
• Working knowledge of a Quality Management System and requirements of ISO 13485, Canadian Medical Devices Regulations SOR/98-282, 21 CFR 820 Quality System Regulations, EU Medical Device Regulations 2017/745, and FDA medical device regulatory paths, particularly 510(k) requirements.

These skills and abilities will help you thrive:

• Thorough understanding of quality assurance concepts and practices.
• Detail-oriented.
• Ability to interpret and apply regulations and compliance concepts.
• Excellent communication skills (written and verbal).
• Demonstrates proactive thinking and actions.
• Has the ability to read and respond to audiences appropriately.
• Familiar with basic test equipment and basic statistical analysis.
• Computer literate (MS Office).
• Ability to work with minimal supervision.

Additional Requirement:

• Some travel and light lifting may be required.

If you would love to be part of the innovation, excitement, and award-winning culture found at StarFish Medical, we encourage you to apply! Don\xe2\x80\x99t meet every single requirement? Studies have shown that women and people of color are less likely to apply for jobs unless they meet every qualification. At StarFish Medical, we are dedicated to building a diverse, inclusive, and authentic workplace. If you\xe2\x80\x99re excited about this role, but your experience doesn\xe2\x80\x99t align perfectly with every qualification, we encourage you to apply anyways. You may be just the right candidate for this or other opportunities at StarFish Medical. If you experience difficulties with the StarFish Medical Job Portal, please reach out to careers@starfishmedical.com with the subject line \xe2\x80\x9cQuality Assurance & Regulatory Affairs Specialist | Job Portal Issue\xe2\x80\x9d. We thank all candidates who apply; however, only those selected for further consideration will be contacted after initial acknowledgment. No phone calls, please. We look forward to meeting you! About StarFish Medical StarFish Medical is a leading North American contract product development and prototype/low-volume manufacturing firm with an award-winning culture focused on the medical and bio-device spaces. We tend to work on complex electromechanical devices across all medical specialties. We have over 200 staff located in two main offices in Victoria and Toronto, Canada, and business development staff across the US and have been in business and growing for 23 years. Our values include innovation, transparency, being aspirational and efficiency. Our job is to enable entrepreneurial medical device companies to improve medical care as their lean med-tech start-up partner assisting them in moving from idea to commercialization with as much founder value intact as possible. Balancing our innovation mandate with reliable execution is a never-ending challenge. We need to be consultative and help our clients become valuable and successful, sometimes in ways they didn\xe2\x80\x99t imagine at the beginning, delivering that value in meaningful and powerful ways to them and their investors. In addition to product development, we also supply intellectual property, regulatory, quality assurance, manufacturing transfer and optimization, supply chain and other complementary services. We are known for innovation, technical excellence, service-oriented culture, and operational systems.