Quality Engineering Specialist - Medical Devices & QMS

Myant Inc; Mississauga; On-site; CAD 90,000 - 130,000; Full time

Job summary

Myant is seeking a Quality Engineering Specialist to strengthen manufacturing processes, supplier quality and QMS compliance in a regulated medical device environment. You will work cross‑functionally to support risk‑based decision making and continuous improvement across design transfer, production, CAPA and supplier qualifications.

The role requires hands‑on quality engineering within medical devices, with experience implementing ISO 13485, ISO 14971, and related standards, and leading pFMEA,

Qualifications

• Bachelor's degree in Engineering and 5+ years of progressive Quality Engineering experience.
• Hands-on experience in a medical device manufacturing environment with QMS basics.
• Strong knowledge of CAPA, FMEA, SPC and supplier quality management.
• Experience with eQMS, audits, regulatory standards and cross‑functional teams.

Responsibilities

• Quality engineering across manufacturing, process control, supplier quality, validation, risk management and continuous improvement.
• Lead or support CAPA investigations relating to defects and process issues.
• Develop inspection criteria, sampling plans and acceptance criteria for materials and finished products.
• Support IQ/OQ/PQ activities and manufacturing validation documentation.
• Drive risk management and integrate risk controls into processes and controls.
• Collaborate with Manufacturing, Engineering, Product, QA and Regulatory teams.

Skills

Quality engineering

Medical device

Risk management

CAPA

Process control

FMEA

Gage R&R

Data analysis

Regulatory knowledge

QMS

Education

Bachelor's degree in Engineering

Tools

eQMS

IQ/OQ/PQ

ISO 13485 knowledge

Job description

Myant is seeking a Quality Engineering Specialist to strengthen manufacturing processes, supplier quality and QMS compliance in a regulated medical device environment. You will work cross‑functionally to support risk‑based decision making and continuous improvement across design transfer, production, CAPA and supplier qualifications.

The role requires hands‑on quality engineering within medical devices, with experience implementing ISO 13485, ISO 14971, and related standards, and leading pFMEA,