Tevosol, Inc. Hiring for Quality Engineer at Edmonton, AB Full Time

Quality Engineer

Job Description

Tevosol Inc. (a Bridge to Life company) develops medical devices that support the preservation, evaluation, and increased utilization of donor organs for lifesaving transplants. The Quality Engineer will work directly with the product development team to support the conformance of products with relevant medical device standards during the development process.

Roles & Accountabilities:

• Standards. Read, understand, and implement appropriate medical device standards for Tevosol’s product portfolio, and ensure conformance with the standards during the development process (ex: ISO 13485, ISO 14971, IEC 60601-1).

• Design Controls. Work collaboratively with the rest of the product development team to create product requirements, technical specifications, and prepare design outputs in accordance with ISO 13485 to meet customer and regulatory requirements.

• Verification & Validation. Develop verification and validation test plans, execute testing, and write detailed test reports.
• Risk Management. Work collaboratively with the rest of the product development team to maintain risk analysis and risk management documentation in accordance with ISO 14971.
• Procedures. Help establish procedures and contribute to the development of an ISO 13485 quality management system (ex: supplier qualification, purchasing, design controls, manufacturing)

Qualifications:

• Degree in an engineering discipline
• Registered with APEGA
• Proficient in Microsoft Office Suite
• Strong multitasking and organizational skills
• Experience with writing quality documentation and working within a quality management system (ISO 9001 or ISO 13485 preferred)
• Understanding of common manufacturing processes, including urethane casting, injection molding, sheet metal, and machining

Job Types: Full-time, Permanent

Salary: From $80,000.00 per year

Benefits:

• Casual dress
• Dental care
• Employee stock purchase plan
• Extended health care
• Flexible schedule
• On-site parking
• Paid time off
• Vision care
• Work from home

Schedule:

• Monday to Friday

COVID-19 considerations:
All employees must be double vaccinated

Education:

• Bachelor’s Degree (required)