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Skills
Analysis Skillsunmatched
Biotech and Pharmaceuticalunmatched
Business Modelunmatched
Certified Quality Engineer (CQE)unmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Corporate Policiesunmatched
Cross-Functionalunmatched
Detail Orientedunmatched
Documentationunmatched
Drug Manufacturingunmatched
FDA (Food and Drug Administration)unmatched
FDA Requirementsunmatched
Follow Throughunmatched
GMP (Good Manufacturing Practices)unmatched
Hazard Analysisunmatched
Health Planunmatched
Healthcareunmatched
ISO (International Organization for Standardization)unmatched
Information Technology/Systems Auditunmatched
Interpersonal Skillsunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Requirementsunmatched
Market Analysisunmatched
Marketingunmatched
Medical Equipmentunmatched
Operations Processesunmatched
Organizational Skillsunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Product Designunmatched
Product Developmentunmatched
Product Documentationunmatched
Product Lifecycleunmatched
Product Managementunmatched
Product Requirements Document (PRD)unmatched
Product Supportunmatched
Product Testingunmatched
Quality Engineeringunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Riskunmatched
Risk Analysisunmatched
Risk Managementunmatched
Team Playerunmatched
Technical Leadershipunmatched
Time Managementunmatched
Description
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.