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Quality Assurance Specialist - 18482
Burnaby, BC V3J 1A1 CA
Job Description
Algiamed Technologies
Contact – Dave Banns (dbanns@theheadhunters.ca or 604.351.6753)
Based in Burnaby, BC, our client, Algiamed Technologies (www.algiamed.com), a cutting-edge medical device company, is looking to add a QA Specialist to their growing local team. Â
Algiamed Technologies are a medical device company that have designed technology focused on utilizing electromagnetic therapy to target the biological root of pathological conditions.  Via their technology, their goal is to regulate the homeostatic control system, leveraging the body’s natural ability to restore its physiological equilibrium to a non-pathological state.
With upcoming new product releases, the QA Specialist will be responsible for managing and improving a variety of quality assurance and compliance processes and ensuring the highest quality production of company products globally.
QA Specialist Responsibilities:
Regulatory Compliance
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- Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings
- Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards
- Assist in creation and maintenance of regulatory files
- Ensure that international and national legislation are applied and adhered to
- Write, analyze, and edit technical documents to support country-specific regulatory submissions
- Compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in RSA, USA, Canada and Europe
- Work with other departments and communicate the submission requirements when documents are needed for regulatory submission
- Assess device related incidents/complaints for medical device reporting requirements
QMS
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- Implement, manage, maintain, oversee, administrate, and implement ISO 13485 requirements and the quality management system.
- Ensure that all facets of the organisation comply with ISO 13485. Ensure that current processes are consistent with established QMS and legal standards.
- Ensure quality systems are appropriately designed, configured, and implemented and measure for compliance and effectiveness.
- Ensure that new procedures or any procedure changes are updated to reflect current practice.
- Lead and manage Quality Management Review process and meetings. Schedule meetings, present metrics, take minutes, and escalate issues accordingly.
- Manage change control through the Quality Management System and ensure that changes are documented and communicated accordingly to all relevant parties.
- Identify and lead quality system changes and continuous improvement initiatives through collaboration and engagement with system users.
- Act as a quality system owner
- Work with all staff to establish quality requirements for external suppliers.
- Ensure that all corrective actions are dealt with accordingly and that they are monitored for statistical purposes
The successful candidate has:Â
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- 3+ years experience in a quality function within the medical device industry
- Relevant Post-Secondary degree in the field of either Biotechnology / Biomedical Science / Pharmaceutical Science and Quality
- Implementation experience with ISO 13485
- Experience building technical files
- Strong and proven relationships in healthcare
- Commercial awareness and in-depth knowledge of the relevant markets and positioning of medical devices
Compensation and Benefits:
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- Competitive Base Salary
- Hybrid Work Option
- Extended medical benefit program
- Opportunity to play an integral role during a significant growth period
Only candidates already eligible to work in Canada will be reviewed. Only qualified candidates will be contacted.
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Meet Your Recruiter
Dave Banns
MBA, Principal
Recruiting Specialty: Engineering & Operations
As Principal, Dave builds and maintains relationships with our partners. Drawing on over a decade of global recruitment and business development experience, his market knowledge is an invaluable resource to organizations of all sizes. Dave has ambitious goals to work collaboratively with current and new clients to develop cutting-edge, proactive workforce solutions. He has a proven record of exceeding clients’ expectations and cultivating sustainable and mutually-beneficial partnerships.
Dave is also a specialized and consultative recruiter with a focus in Engineering, Manufacturing, Construction and Operations positions. He has a reputation among his clients for implementing unique search strategies to attract top talent and build cohesive teams. Dave has a realistic understanding of how his clients’ businesses function in today’s world and what they will need to thrive in the future. Moreover, he has a deep network, refined ability to spot technical talent and match it with the most suitable company culture.
A former teacher, Dave knows how best to coach and guide individuals he works with. He takes the time to fully understand their goals, encouraging them to develop and follow a career path that is unique to their skills, talents and aspirations. Working with them as their consultant, he opens doors, acting as a conduit between great candidates and high-calibre career opportunities.
Dave holds an MBA in Global Management and a BBA in Marketing. He is an enthusiastic supporter of Big Brothers of Canada and the Make-A-Wish Foundation, and is a Board member for The Vancouver Society of Children’s Centres, where he sits on the HR & Governance, Finance and Nominations Committees. He is an avid traveler and sports enthusiast, coaches his son’s tee-ball and soccer teams, and enjoys hockey, golf, cycling, baseball, basketball, tennis and skiing.
