Manufacturing Quality Specialist, Intermediate - Toronto, Canada - Synaptive Medical Inc.

Synaptive Medical Inc.

Verified Company

Toronto, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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 subcomponents
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 nonconformance 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 rollout to employees

What you'll Need

35 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

Selfmotivated and selfmanaging
Ability to work in a highlytechnical, fastpace 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