Quality Engineer II

Our client, a Medical Device and Healthcare company, is looking for a Quality Engineer II for their Scarborough, MElocation.

Responsibilities:

• Works closely with development/manufacturing/quality engineering to establish and ensure compliance and quality for product related risk management documentation. Ensure risk management assessments and evaluations for products conform to established standards and agency regulations.
• This role will support product risk management activities across the product lifecycle, including evaluating risks associated with complaints, manufacturing non-conformances, and new product development.
• The Quality Engineer II will work cross-functionally with Engineering, Manufacturing, Regulatory, and Quality teams to establish and maintain compliant risk management documentation in alignment with FDA regulations and ISO standards.
• Responsibilities include performing hazard and risk assessments, contributing to continuous improvement of risk management processes, and ensuring product risk documentation is accurate, complete, and audit-ready.
• A strong understanding of complaint handling, health hazard assessments, and medical device regulatory environments is preferred.
• Perform risk evaluations associated with complaints, manufacturing non-conformances and new product design activities.
• Proactive in finding quality improvements related to Risk Management processes.
• Works cross functionally with Engineering, Marketing, Manufacturing and Regulatory to establish product risk documentation.
• Work collaboratively with operations engineering, complaint handling team, product development and design assurance.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements:

• Bachelor's degree in Engineering or related technical field
• Minimum 3 years of experience in quality engineering within a regulated environment (medical device, pharmaceutical, or similar)
• Hands-on experience with product risk management, including hazard analysis and risk assessments (ISO 14971)
• Experience supporting complaint investigations, non-conformance evaluations, or health hazard assessments
• Working knowledge of FDA regulations, ISO standards, and quality systems
• Proven ability to collaborate cross-functionally with Engineering, Manufacturing, and Regulatory teams
• Strong analytical, problem-solving, and documentation skills
• Certified Quality Engineer (CQE) or equivalent
• Experience with GMP environments and quality system audits
• Exposure to new product development and design assurance activities
• An equivalent combination of education and work experience
• Minimum 2 years, in a medical device, regulatory environment or pharmaceutical manufacturing.
• Preferred understanding of complaint management and Health Hazard Assessments for on-market (distributed) products.
• Must have fundamental knowledge of concepts, practices, and procedures of a particular field of specialization.
• Credentials of a Certified Quality Engineer are a plus.
• Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired.
• Must possess good communication and analytical skills.
• Ability to work under deadlines.
• Demonstrated use of Quality tools/methodologies.
• Solid communication and interpersonal skills.
• Ability to resolve quality-related issues in a timely and effective manner.
• Demonstrates technical leadership within the department and outside the department.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong organizational and follow-up skills, as well as attention to detail.

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities