Quality Assurance and Regulatory Affairs Specialist - Jobs in Victoria

Job Description

StarFish Medical, a leading product development consultancy with offices in Victoria, BC, and Toronto, ON, we are offering an exciting opportunity for a Quality Assurance and Regulatory Affairs Specialist. Reporting to the QA/RA manager, you will become an indispensable member of our Quality Assurance/Regulatory Affairs team. In this role, you will be the driving force, ensuring the highest quality and compliance standards are maintained across the entire medical device development and manufacturing lifecycle. Join our innovative team and bring your expertise in quality assurance, regulatory affairs, design assurance and quality engineering to enhance our dedicated workforce. Your contributions will be instrumental in guaranteeing that product specifications are met and implementing StarFish Medical #39;s standard operating procedures (SOPs). Your specialized skills will play a pivotal role in shaping the future of medical device development at StarFish Medical.Are you passionate about medical technology and driven by a commitment to quality and compliance If you are a motivated, detail-oriented individual with a deep appreciation for maintaining a culture of quality and helping project teams succeed, and you can inspire others to share this vision, we want to hear from you!StarFish Medical offers the Quality Assuranceamp; Reg. Affairs Specialist:

• Award-winning culture with strong core values
• Intrinsic reward - helping humanity through innovative medical devices
• Competitive compensation
• Profit-sharing
• Excellent company-paid benefits package
• Paid vacation and sick leave
• Monthly All-hands meetings and social events that happen both during the workday and outside of work hours
• 50% BC Transit / TTC cost-sharing in Toronto
• Both locations offer shower facilities for midday runs or biking to work, and Victoria offers Galloping Goose access close by, while Toronto offers a Bike Share station within 5 minutes #39; walk to the office
• Both locations offer free parking on-site or around the premises

Your day may include:

• Review and potentially take on the responsibility of authorizing SOPs (Standard Operating Procedures) and Work Instructions, with minimal supervision
• Collaborate closely with personnel to resolve all issues resulting from DHF (Design History File) reviews, including document corrections, deviations, and clarifications
• Participate in internal audits of the Quality Management System, compile audit reports, and follow up on nonconformances
• Maintain communication with internal teams within Starfish Medical and clients to resolve quality issues to support batch release and disposition
• Participate actively in Risk Assessment and Analysis sessions
• Contribute input to regulatory strategy and participate in regulatory submissions

This is an abridged version of the responsibilities; kindly review the full at https://starfishmedical.com/jobs/quality-assurance-regulatory-affairs-specialist to understand the full scope of duties.Our ideal candidate for this role brings:

• Bachelor #39;s degree in a technical or scientific field
• Minimum of 3+ years of work experience in quality assurance and/or regulatory affairs role in a regulated environment, preferably medical devices or 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, and EU MDRamp; IVDR and 510 (K) requirements

These skills and abilities will help you thrive:

• Thorough understanding of quality 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

If you feel that you would be suitable for this position, please apply through the StarFish Medical Job Portal. We look forward to meeting you!About StarFish MedicalStarFish Medical is Canada #39;s leading Medical Device Design service provider with a full complement of design, development, and manufacturing services in Victoria and Toronto. We successfully partner with innovative companies (both large and small) to create breakthrough products for a number of medical specialty areas.Medical device product definition using our proprietary Pathfinder process enhances technical engineering and product development. Prototype and volume production are delivered in an ISO 13485 certified facilities with class 10,000 clean room capabilities.Our work environment received the Canada #39;s Most Admired Corporate Cultures for 2021 and 2022 awards recognizing best-in-class cultures that have helped enhance performance and sustain a competitive advantage.Don #39;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 #39;re excited about this role but your past experience doesn #39;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.If you experience any difficulties with the StarFish Medical Job Portal, please reach out to careers@starfishmedical.com with the subject linequot;QARA| Job Portal Issue. quot;We thank all candidates who apply; however, only those selected for further consideration will be contacted following initial application acknowledgement. No phone calls, please.