Design Assurance Specialist – QA/RA Team

at  Starfish Medical

StarFish Medical, a rapidly growing medical device design and development company, is dedicated to helping innovators create breakthrough products that improve health and save lives. With teams in Victoria and Toronto, we are seeking a talented and motivated Design Assurance Specialist to join our Quality Assurance and Regulatory Affairs team.

THESE SKILLS AND ABILITIES WILL HELP YOU THRIVE:

• Thorough understanding of quality and design assurance concepts and practices.
• Display strong attention to detail.
• Keen ability to interpret and apply regulations and compliance concepts.
• Excellent communication skills, both in written and verbal forms.
• Has the ability to read and respond to audiences appropriately.
• Proficient in MS Office Suite: Intermediate proficiency in Excel, Outlook, Word, and PowerPoint.
• Ability to work with minimal supervision.

AMAZING CULTURE!

Our work environment received Canada’s Most Admired Corporate Culture awards for 2021, 2022 & 2023, recognizing best-in-class cultures that have helped enhance performance and sustain a competitive advantage. We are Canada’s leading medical device design service provider, providing a full complement of design, development, and low-contract manufacturing services in Victoria and Toronto. We successfully partner with innovative companies (both large and small) to create breakthrough products for several medical specialty areas.
Don’t meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At StarFish Medical, we are dedicated to building a diverse, inclusive, and authentic workplace, so if you’re excited about this role but your past experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles! Please apply through the StarFish Medical Portal.
We thank all candidates who apply; however, only those selected for further consideration will be contacted following initial application acknowledgement. No phone calls, please.

ABOUT THE ROLE:

Are you passionate about medical technology and driven by a commitment to quality and regulatory compliance? We’re looking for a detail-oriented and proactive professional with proven experience in design and development processes, ensuring compliance with all relevant regulations and standards. In this hands-on role, you’ll collaborate closely with the System Engineering Team to ensure that complex, multidisciplinary products meet all regulatory requirements.
Your focus will be on documentation throughout every phase of the development lifecycle, ensuring the successful launch of new products that meet the highest quality and safety standards.

WHAT YOU’LL BE DOING:

• Provide proactive input to projects, ensuring compliance and best practices for development are followed.
• Provide project support by collaborating with external clients and internal colleagues to ensure QA/RA requirements and milestones are met.
• Draft and review DHF documentation with input from project teams, ensuring alignment with regulatory and quality standards.
• Resolve issues from DHF reviews, such as document corrections, deviations, and clarifications.
• Participate in Engineering Design Reviews, providing input into regulatory strategy and compliance.
• Participate in risk management and requirements generation activities as needed.
• Provide input into testing documentation, including justifications for deviations, non-conformances, or exemptions.
• Oversee prototype builds and perform reviews of DHR to ensure accuracy and compliance.
• Communicate with internal teams and clients to resolve quality issues related to prototype release and disposition.
• May support the QMS by:
• Review and author SOPs and Work Instructions with minimal supervision.
• Conduct internal audits of the quality management system, prepared audit reports, and followed up on non-conformances.
• Assist with external audits, regulatory agency inspections as required and support regulatory submissions.
• Follow up on CAPAs, NCRs, and ECRs; participate in root cause analysis.