Manufacturing Quality Specialist, Intermediate
3 weeks ago
About Us
Synaptive Medical is a Canadian medical device company, based in downtown Toronto, focused on supporting healthcare professionals and systems in patient diagnosis and treatment. Synaptive’s suite of products include MRI, surgical planning, navigation, and robotic visualization - all of which can be seamlessly combined or used independently in the operating room. The company has a number of opportunities for innovative people to join the team and share in the development of technologies to solve surgical and imaging challenges in patient care.
The Opportunity
The Manufacturing Quality Specialist will be accountable for relevant deliverables for assigned products through their lifecycles including design and development, production, and post market, and support the continuous improvement of an ISO 13485:2016 compliant quality management system.
What You’ll Do
- Work closely with Systems and Manufacturing Engineering teams to ensure effective development and deployment of design transfer protocols and release activities for production
- Define and execute manufacturing process validation activities resulting from design transfer activities or major process changes
- Lead the creation of manufacturing quality instructions and processes for a variety of products and sub-components
- Qualifying and auditing suppliers to ensure ongoing conformance to established acceptance criteria for products and services
- Participate in product design reviews as appropriate, to support compliance to quality standards and component manufacturability
- Oversee First Article Inspection, incoming inspection, and supplier end of line inspection planning
- Ensure appropriate qualification of production tooling and support ongoing internal and external calibration activities
- Drive non-conformance report processing and root cause analysis for supplier, production, and post market defects
- Lead CAPA and SCAR processes to implement timely and effective internal and external corrective actions to identified issues
- Accountable for finished device release for shipment, and DHR acceptance criteria
- Support the document control system and process for all company business and project documentation
- Drive improvement in the QMS process and tools, and assist with the roll-out to employees
What you’ll Need
- 3-5 years of relevant experience
- Bachelor’s degree in Mechanical, Electrical, Systems or Biomedical Engineering, or equivalent
- Experience in document control, supplier audits, and calibration systems in a regulated environment
- Experience in troubleshooting and root cause analysis
- Experience developing V&V methodologies in a highly regulated industry
- Experience developing receiving inspection instructions and documentation - using language appropriate to the audience
It’d Be Amazing if You Had
- Knowledgeable in the following standards: IEC 60601, ISO 13485, ISO 14971, IPC standards
- Experience in the design, development, and testing of medical devices
- Experience with electrical and mechanical component testing
- Experience with SolidWorks EPDM
- Experience with New Product Introductions, understanding of QA and risk management principles in the product lifecycle
About You
- Self-motivated and self-managing
- Ability to work in a highly-technical, fast-pace environment
- Ability to communicate clearly and effectively even when presenting product issues to owners of product’s design and architecture Organizational Considerations
- Enjoys solving technical problems
- Friendly and relaxed; a sense of humour is always appreciated
COVID-19 Considerations
Diversity & Inclusivity
Synaptive is based out of one of the most diverse countries in the world. This includes differences related to race, ethnicity, national origin, gender, gender expression and presentation, sexual orientation, religion, age, ability and socioeconomic status. To us, diversity is one our strongest assets to our organization. We commit ourselves to promoting the recognition and appreciation of our diverse and rich culture. We believe that it is critical to our success to promote freedom of thought and opinion in a respectful environment. The decisions we make are rooted by respectfully considering each other’s thoughts and opinions and by working towards a greater common goal, saving lives.
Accommodation
How to Apply
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