Canada-Quality Manager II (Engineering)

$114,400 - $124,800/Yr

Talentburst - Toronto, OH

Full-time - Mid Level

Toronto, OH

Administrative and Support Services

About the position

The Quality Manager II (Engineering) position is responsible for ensuring compliance with FDA/EU quality standards and validation requirements within a GMP regulated environment. The role requires strong communication skills, strategic thinking, and the ability to work effectively in a cross-functional team. The manager will oversee quality processes, documentation, and validation systems, ensuring that timelines and deliverables are met while maintaining a high standard of quality.

Responsibilities

• Ensure compliance with FDA/EU quality standards and validation requirements.
• Communicate effectively across multiple layers of the organization.
• Work collaboratively in a cross-functional team environment.
• Make balanced quality decisions in a fast-paced setting.
• Oversee the review and auditing of GMP documentation.
• Utilize Document Management Systems and Change Management applications as needed.
• Manage computerized systems validation, including Delta V and MES.

Requirements

• Bachelor's Degree in Science or Engineering.
• 5+ years of experience in a GMP regulated environment.
• Minimum 5 years' experience in review and auditing of GMP documentation.
• Strong technical background in FDA/EU quality compliance and validation requirements.
• Excellent interpersonal and influencing skills.

Nice-to-haves

• Experience with Document Management Systems (e.g., QualiPSO).
• Trained in Change Management, Nugenesis, and Kneat Paperless Validation system.
• Experience with computerized systems validation.

Benefits

• Competitive hourly rate of $55-$60 per hour.
• Opportunity to work in a diverse and fast-paced environment.