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Manager of Quality Assurance & Regulatory Affairs

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Location
Toronto, ON
Job Type
Direct Hire
Date
Jun 22, 2018
Job ID
2593468
The Manager of Quality Assurance and Regulatory Affairs (QA/RA) is responsible for planning, leading and executing all quality assurance and regulatory affairs activities to support a growing and dynamic business comprised of diagnostics products and services. The Manager QA/RA leads a team of QA RA personnel that ensures the effective implementation of the ISO 13485-certified Quality Management System (QMS) and compliance to market-specific regulatory requirements.

Responsibilities:
Quality Assurance
• Acts as Management Representative; reports to Executive Management on the effectiveness of the QMS; proposes, sets and implements improvement initiatives and annual quality objectives 
• Promotes awareness of applicable regulatory and QMS requirements throughout the organization
• Leads the design, development, and manufacture of’ products and services; ensure compliance to applicable standards, regulations, and laws; meets or exceeds internal and customer quality requirements.
• Works strategically with fellow leaders in Manufacturing, Product Development, Engineering, Customer Service and other departments.
• Develops and maintains Key Performance Indicators, ensuring high visibility within organization
• Generates, reviews and revises quality documentation, including corporate quality procedures and the quality manual 
• Administers and maintains an efficient and compliant electronic QMS (eQMS); authorizes the release of controlled documents 
• Supports Supply Chain by facilitating supplier performance reviews, trending results of supplier audits, maintaining supplier score cards, approving suppliers, and leading supplier corrective action requests (SCARs)
• Ensures that released product conforms to the QMS and complies to applicable regulations
• Manages the internal audit programme, and lead external audit preparations and responses
• Leads the CAPA system; directs cross-functional teams during root cause analysis sessions
• Responsible for all Risk Management processes; participates in risk analysis during all phases of the development and production processes
• Coordinates, in conjunction with supervisors, training required for all company personnel 

Regulatory Affairs
• Leads regulatory strategy and product regulatory submissions 
• Keeps organization current with applicable standards and regulations; manage standards documentation and certification schedules
• Ensures that the establishment and device licenses are kept up to date
• Informs applicable regulatory authorities regarding reportable events, communications, field actions and/or recalls
• Manages external QA and RA consultants 
Education, Qualifications and Requirements:
• University degree in a science or engineering discipline required
• Minimum 8 years of experience in Quality Assurance and Regulatory Affairs in medical device or related industry; minimum 2 years experience of managing QA and/or RA function with progressively senior positions
• Excellent knowledge of and experience with 21 CFR 820, ISO 13485, and ISO 14791 in a Manufacturing and Research &

Development organization 
• Experience in OEM and New Product Introduction projects
• Regulatory submissions to US FDA 510(k), Canadian Medical Device Regulation (CMDR) and European IVDD
• Quality Assurance certification (ASQ, other)
• Experience in electronic document control and paper record management
• Demonstrated leadership of people 
• Quality System audit experience 

Other Required Skills:
• Lead and manage effective teams, with direct and indirect reports
• Ability to lead strategic planning and initiatives in QA and RA
• Ability to prioritize and align to business objectives
• Organized, attentive to detail, and able handle multiple projects with competing deadlines
• Electronic data management (metrics, KPIs, statistics, statistical process control)
• Works efficiently both on independent basis and as part of a team
• Project management skills
• Demonstrated problem solving skills
• Excellent written and verbal communication skills, strong interpersonal skills

General Description of Leadership Level
• Work tasks have a high degree of complexity 
• Percentage of independent work is up to 90%
• Financial accountability: establish and meet departmental budgets
• Leads and directs external vendor/partner/client relationships
• Leads people directly (or indirectly) in a project/team environment
• Responsible to establish and deliver key business objectives in department
• Leadership shapes department culture

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KNG gets high demand for professionals in R&D, Engineering, Chemistry, Science and technology, manufacturing, Quality, Regulatory affairs, Process, and Facilities.

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