We have a new opportunity for a Senior Quality Assurance and Regulatory Affairs Specialist in Toronto, ON, or 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 devices product development and manufacturing departments. The Senior Quality Assurance & Regulatory Specialist will meet product specifications and enforce StarFish Medical’s 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 quality culture 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
- 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 /TTC Transit cost-sharing in Victoria & Toronto, respectively.
- Review and/or write SOPs (Standard Operating Procedures) and Work Instructions.
- Participate in internal audits of the Quality Management System, prepare audit reports, and follow up on non-conformances.
- Handle regulatory agency and client inspections as required.
- Follow up on CAPA, (Corrective Actions Preventive Actions) & participate in root causes analysis.
- Support Product Development and Manufacturing systems improvements as appropriate.
- Participate in developing and training on quality and regulatory courses as needed.
- Provide data for preparation of monthly Quality Assurance reports including quality issues by product, metrics, and summary of any quality problems.
- Periodically assist with preparation of Management reports.
- Assist Project Managers with documentation required for regulatory submissions: Review design inputs for regulatory compliance.
- Review design outputs for regulatory compliance (60601, 14971, RoHS, etc.).
- Participate in Risk Assessment and Analysis sessions as required.
- Review DHF, DMR and DHRs including verification and validation documents during product development and manufacturing.
- Review Quality Plans during product development.
- Participate in Project Kick-off meetings, Engineering Design Reviews, and Gate Reviews.
- Monitor the effectiveness of product Quality testing including Documentation of final test results.
- Identify manufacturing process issues based on product testing results.
- Monitoring the effectiveness of product Quality testing including review of Device History Records and product release.
- Communicate with internal groups at StarFish Medical and clients to resolve quality issues to support batch release and disposition.
- Following-up on NCRs (Non-Conformance Report) & participate in root causes analysis.
- Manage and drive solutions to NCRs, customer complaints and vendor corrective actions.
- Provide input on decisions to approve/reject ECRs (Engineering Change Requests) & participate in root causes analysis.
- Review of internal and external change control documents related to the manufacturing process.
- Work closely with personnel to resolve all issues resulting from document review (document corrections, deviations, and clarifications).
- Interact and communicate effectively with all departments of StarFish Medical, ViVitro Labs Inc., the customer base, regulatory bodies, and any related contracting services.
- Provide guidance and input on QA and RA issues for PD and Manufacturing projects, support improvements as appropriate.
- Deliver client QMS development solutions against customer contracts.
- Provide regulatory support for new products and supports or handles regulatory submissions.
- Bachelor’s degree preferably in engineering, technical or science field with a minimum of 7 years of work experience in quality assurance and/or regulatory affairs role in GMP (Good Manufacturing Practices) regulated environment, preferably medical devices or equivalent combination of education and experience.
- Minimum 5 years’ experience working in a medical device consultancy. Management experience in high-tech industry desirable.
- In depth understanding 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 MDR & IVDR.
- Lead ISO 13485 Auditor, ASQ, SQA or RAPs RAC certification desirable.
- Thorough understanding of quality assurance concepts and practices.
- Detailed oriented.
- Ability to interpret and apply regulations and compliance concepts.
- Excellent communication and negotiation skills (written and verbal).
- Strong auditing skills with experience of creating and driving improvements based on findings.
- Demonstrates proactive thinking and actions.
- Ability to read and respond to audiences appropriately.
- Computer literate (MS Office).
- Ability to work with minimal supervision.
About StarFish Medical
StarFish Medical is a leading North American contract product development and prototype/low volume manufacturing firm focused on the medical and bio-device spaces with an award-winning culture. 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’t 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.
How To Apply:
Qualified Senior Quality Assurance & Regulatory Specialist applicants are encouraged to apply through the brand new StarFish Medical Job Portal with a resume and cover letter that clearly indicates how your education and experience meet the requirements of this position.
If you experience any difficulties with the StarFish Medical Job Portal, please reach out to email@example.com with a subject line of “Senior Quality Assurance & Regulatory Specialist Job Portal Issue”.
We thank all candidates who apply; however after initial acknowledgement, only those selected for further consideration will be contacted.