Lynx Compliance Inc. Hiring for Quality Engineer at Toronto, ON Full Time

About us

Lynx Compliance Inc. is an Engineering & Regulatory Service Provider for Medical Device and Pharmaceutical Manufacturers working on Design and Development, Process Validation & Improvement, Engineering documentation, Software Validation, and Risk Management. We offer an impressive portfolio of professional consulting services that are completely specialized for your business.

Job description

Must-haves

• Bachelor’s degree in a scientific discipline, preferably engineering
• Working knowledge of Medical Device Regulations and International Standards such as European Good Manufacturing Practices including Directive 93/42/EEC, as amended, EU Medical Device Regulation 2017/745 and US FDA 21 CFR 820, ISO 13485:2016 required
• Strong Supplier Quality and Process Validation Skills (IQ, OQ, PQ, PVE) and experience essential to success in this role
• EUMDR experience

Day-to-Day:

Lynx Compliance is looking for a Senior Quality Engineer for one of our largest medical device clients to support EUMDR. This candidate specifically will support their specialty surgeries division to lead EUMDR Class 2 and 3 compliance projects. They will work in a cross-functional team to assess Supplier Validations for compliance to EUMDR requirements and perform gap assessments, specifically related to Process Validation as well as prepare Progress Reports and Metrics for review by Sr. Management. Finally they will supervise and oversee supplier quality engineers supporting this audit compliance project.

Contract length: 12 months

Expected start date: 2021-10-04

Job Types: Full-time, Contract

Salary: $70,000.00-$90,000.00 per year

Benefits:

• Flexible schedule
• Work from home

Schedule:

• Monday to Friday

Education:

• Bachelor’s Degree (preferred)

Work remotely:

• No