Job Description

Quality Engineer

Our client is a fast growing medical device company with offices in Toronto and California. They are looking for a Quality Engineer to join their team.

As a Quality Engineer, you will be responsible for building and implementing a QMS from the ground up, guiding the organization from inception to the successful shipment of a medical device. This role requires a deep understanding of CFR regulations, QMS standards like ISO 13485, and the ability to collaborate with cross-functional teams to establish processes that meet regulatory requirements while supporting efficient product development and manufacturing. 

Role and Responsibilities:

• Design, develop, and implement a robust QMS aligned with ISO 13485, 21 CFR Part 820, and other applicable regulatory requirements. 
• Lead the organization through the QMS implementation process, including creating policies, procedures, work instructions, and templates. 

• Collaborate with cross-functional teams to integrate QMS processes into product development, manufacturing, and supplier management workflows. 

• Ensure compliance with design controls, risk management (ISO 14971), and document controls to support product development and regulatory submissions. 

• Establish and oversee internal and external audit programs to ensure QMS compliance and continuous improvement. 

• Facilitate training for employees on QMS processes, regulatory requirements, and quality best practices. 

• Manage and monitor CAPAs, non-conformances, and other quality processes, ensuring timely resolution and preventive actions. 

• Provide guidance and support for achieving regulatory approval and clearance, including FDA and MDR submissions. 

• Support cross-functional teams in verification, validation, and human factors engineering activities to ensure product safety and efficacy. 

Qualifications:

• Bachelor’s degree in Engineering, Quality Assurance, or a related field. 
• 8+ years of experience in quality engineering, with direct experience in medical devices or regulated industries. 
• Proven track record of building and implementing a QMS from inception through product commercialization. 
• Deep knowledge of CFR regulations, including 21 CFR Part 820, and familiarity with FDA QSR, EU MDR, and other global regulatory frameworks. 
• Hands-on experience with ISO 13485 QMS implementation and maintenance. 
• Strong understanding of risk management (ISO 14971), design controls, and validation/verification processes. 
• Experience leading internal and external audits and working with third-party testing organizations. 
• Exceptional problem-solving, organizational, and communication skills. 
• Experience with software as a medical device (SaMD) or digital health products. 
• Familiarity with IEC 62304 (medical device software lifecycle processes). 
• Certifications such as CQE (Certified Quality Engineer), CQA (Certified Quality Auditor), or RAC (Regulatory Affairs Certification). 
• Proven ability to lead teams through regulatory submissions and successfully obtain product clearances. 

Ruth Adole, Recruitment Consultant
Phone: (905) 477-3315 Ext. 306
Toll Free: 1 (888) 931-3315
Email: ruth@mtsrecruiting.com
Website: www.mtsrecruiting.com

Job Tags

Direct hire,

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