Design Assurance Specialist

3 months ago

Victoria, Canada StarFish Medical Full time

**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.

**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.

**Salary & Benefits**:
The annual base salary for this role is listed below.

**Location**:
Victoria, BC or Toronto, ON

**Base salary range is between**:
**Comp Philosophy**:
**Benefits of working at StarFish Medical**:
An exciting career working with a genuinely talented and ambitious team, combined with:

- Award-winning culture with strong core values
- Intrinsic reward - helping humanity through innovative medical devices
- Profit-sharing
- Excellent company-paid benefits package for you and your family
- Paid vacation and sick leave, including a "vacation purchase program" to take more time off
- 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’ walk to the office
- Both locations offer free parking on-site or around the premises

**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 mínimal 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.

**What We’re Looking For**:
The StarFish team is talented, innovative, and passionate about developing cutting-edge medical devices for our clients to improve people's lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we constantly have breakthroughs on the most complex devices.

**You are suited to our approach and possess these attributes**:

- Post-secondary education in a technical or science field, with a minimum of **3 years** of work experience in quality assurance and/or regulatory affairs in a 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 **ISO 13485**, Canadian Medical Devices Regulations SOR/98-282, 21 CFR 820, EU MDR 2017/745, and FDA medical device regulations, especially 510(k).

**These skills and abilities will help you thrive**:

- Thorough understanding of quality and design assurance concepts and practices.
- Display strong attention to detail.
- 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 mínimal supervision.

**Additional Requirement**:

- Some travel and light lifting may be required.

**Amazing Culture**

Our work environ

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