Senior Quality Engineer – Medical Devices, ISO 13485 Expert

ZEISS Group; Canada; On-site; CAD 146,641 - 183,232; Full time

Benefits offered by this job

Performance bonus

Medical plans

Retirement savings plan

Paid time off

Job summary

A global technology company in Canada is seeking a Senior Quality Engineer to ensure compliance with medical device regulations, oversee quality systems, and support continuous improvement. The ideal candidate has over 7 years of experience in engineering or quality, and a strong understanding of FDA and ISO standards. This full-time position offers a competitive salary range of $104,600 – $130,700 along with robust benefits.

Qualifications

• 7+ years’ experience in engineering or quality.
• 3+ years’ working knowledge of FDA medical device regulations and ISO 13485.
• Experience with Quality Management Systems and internal audits.

Responsibilities

• Ensure compliance with ISO 13485 and FDA regulations.
• Devise methods for inspecting and evaluating products.
• Support risk assessment processes for manufacturing.

Skills

Engineering

Quality Management Systems (QMS)

Root Cause Analysis

Risk Management

Statistical Methods

Education

BS in Engineering (Mechanical, Industrial/Manufacturing, Biomedical)

Job description

A global technology company in Canada is seeking a Senior Quality Engineer to ensure compliance with medical device regulations, oversee quality systems, and support continuous improvement. The ideal candidate has over 7 years of experience in engineering or quality, and a strong understanding of FDA and ISO standards. This full-time position offers a competitive salary range of $104,600 – $130,700 along with robust benefits.