Document controller Jobs in Quinte West, ON

We are seeking an experienced Quality Assurance & Regulatory Affairs Manager to lead and strengthen the organization’s quality and compliance functions within a manufacturing setting. This role is responsible for overseeing the Quality Management System (QMS), ensuring products meet rigorous safety, quality, and regulatory standards.

The ideal candidate brings a strong blend of technical expertise, leadership capability, and a continuous improvement mindset to drive operational excellence across the organization.

Reporting Structure

• Reports to: Corporate Director of Regulatory Compliance
• Dotted line to: Site VP / General Manager

Key Responsibilities

• Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in alignment with applicable regulatory and industry standards
• Drive quality initiatives to enhance product consistency, process validation, and compliance
• Develop and execute quality strategies, including testing, documentation, and risk mitigation plans
• Maintain a strong presence on the production floor, collaborating with cross-functional teams to resolve issues and improve processes
• Supervise, mentor, and develop the Quality team, fostering a high-performance and collaborative culture
• Promote a leadership approach focused on guidance, accountability, and team development
• Partner with leadership to define quality objectives, KPIs, and strategic priorities
• Lead audit readiness and response activities, ensuring timely corrective and preventive actions
• Oversee complaint handling, internal audits, calibration programs, and manufacturing quality support
• Utilize tools such as FMEA, DOE, PPAP, SPC, and Six Sigma to improve processes and reduce variability
• Analyze performance data to identify trends and drive data-informed improvements
• Ensure compliance through environmental monitoring and adherence to regulatory requirements
• Support organization-wide training initiatives related to quality systems and standards
• Act as a subject matter expert in process validation, inspections, testing, CAPA, and regulatory interpretation

Qualifications & Experience

• 7+ years of progressive experience in Quality Management within a manufacturing environment
• Strong analytical and problem-solving skills with an engineering-driven mindset
• Expertise in quality systems, regulatory compliance, and industry standards
• Solid experience with change control, document control, and quality assurance methodologies
• Hands-on experience with risk management, product testing, and process capability analysis
• Proficiency in APQP, FMEA, Gage R&R, PPAP, and statistical analysis tools
• Excellent communication and technical writing skills, with the ability to present complex information clearly
• Lean and Six Sigma experience is highly preferred
• Proven leadership experience with a track record of building and developing high-performing teams
• Strong organizational skills with the ability to manage multiple priorities
• Strategic thinker with a focus on continuous improvement and operational excellence

AI-enabled tools may be used to sort applications based on job-related criteria. All AI generated results are vetted by our team and the decision of which candidates move forward is always made by a human.

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