Quality Systems Spec
Careers that Change Lives
• Reporting to the Manager, Quality Systems, the Specialist, Quality Systems is responsible for the monitoring and maintaining of the quality systems activities related to various quality assurance and compliance activities to ensure that the functions carried out at Medtronic Canada meet the requirements for the Quality Management System (QMS) certifications, Corporate, and local regulatory requirements. He/she shall
pro-actively identify, facilitate and communicate Quality System and Processes to ensure compliance by all the governing regulatory requirements
A Day in the Life
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Co-ordinates legal requests in support of government investigations or litigations.
• Reporting to the Manager, Quality Systems, the Specialist, Quality Systems is responsible for the monitoring and maintaining of the quality systems activities related to various quality assurance and compliance activities to ensure that the functions carried out at Medtronic Canada meet the requirements for the Quality Management System (QMS) certifications, Corporate, and local regulatory requirements. He/she shall
pro-actively identify, facilitate and communicate Quality System and Processes to ensure compliance by all the governing regulatory requirements
A Day in the Life
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Co-ordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
• Responsible for reporting complaints and Adverse Drug Reactions (ADR)
• Maintain and institutes a QMS consistent with operations at Medtronic Canada, Health Canada, and other quality system requirements.
• Evaluates and identifies resolution of product or system quality issues.
• Coordinates, reviews, assembles the Management Review presentations and
meetings by working with the Manager, Quality Systems and cross-functional teams to ensure Management Review readiness and in compliance with the Site Management review process.
• Performs Internal and external audits of all areas that impact the QMS covering Good Manufacturing Practices for Drugs regulations, Cells, Tissues and Organs (CTO), Canadian Medical Devices Regulations (CMDR), and Corporate Policies and ensure corrective actions are completed and reported to the Supervisor, Quality Systems for review.
• Develop, implement, and provide recommendations of QMS documents such as Standard Operating Procedures (SOPs) per Quality policies, Change control implementation and procedures per local regulatory requirements.
• Partner with the Americas Shared Services Center to initiate, coordinate, and participate in the assessment and recommendations of CAPAs, Deviation, data and documentation reviews and analysis reporting in response to procedural or regulatory commitments.
• Evaluates and ensures the effectiveness of corrective and preventative actions.
• Conduct trainings to facilitate compliance and procedural requirements to all staff when required.
• Provide technical quality systems support for internal and external customer requests.
• Maintain and ensure all quality and regulatory records are properly and adequately maintained in accordance with regulatory requirements and internal processes.
• Support or lead special QARA projects and assignments as required.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
• Responsible for reporting complaints and Adverse Drug Reactions (ADR)
• Maintain and institutes a QMS consistent with operations at Medtronic Canada, Health Canada, and other quality system requirements.
• Evaluates and identifies resolution of product or system quality issues.
• Coordinates, reviews, assembles the Management Review presentations and
meetings by working with the Manager, Quality Systems and cross-functional teams to ensure Management Review readiness and in compliance with the Site Management review process.
• Performs Internal and external audits of all areas that impact the QMS covering Good Manufacturing Practices for Drugs regulations, Cells, Tissues and Organs (CTO), Canadian Medical Devices Regulations (CMDR), and Corporate Policies and ensure corrective actions are completed and reported to the Supervisor, Quality Systems for review.
• Develop, implement, and provide recommendations of QMS documents such as Standard Operating Procedures (SOPs) per Quality policies, Change control implementation and procedures per local regulatory requirements.
• Partner with the Americas Shared Services Center to initiate, coordinate, and participate in the assessment and recommendations of CAPAs, Deviation, data and documentation reviews and analysis reporting in response to procedural or regulatory commitments.
• Evaluates and ensures the effectiveness of corrective and preventative actions.
• Conduct trainings to facilitate compliance and procedural requirements to all staff when required.
• Provide technical quality systems support for internal and external customer requests.
• Maintain and ensure all quality and regulatory records are properly and adequately maintained in accordance with regulatory requirements and internal processes.
• Support or lead special QARA projects and assignments as required.
• Performs additional related duties as required.
Must Have: Minimum Requirements
• Minimum of 2 years of relevant experience, with a bachelor's degree, or;
• No minimum years of relevant experience, with an advanced degree.
SKILLS/COMPETENCIES
• Thorough understanding of ISO 13485 requirements, Good Manufacturing Practices (GMP) for Drugs regulations, Cells, Tissues and Organs (CTO), Canadian Medical Devices Regulations (CMDR) and Corporate Policies.
• Team player with very strong interpersonal skills.
• Strong problem solving and organizational skills.
• Detail oriented, accurate, and results driver.
• Works independently under limited supervision.
• Works in teams or projects and effectively interacts with other departments.
• Ability to manage multiple priorities in a fast-paced environment.
• Supports overall department needs as necessary.
• Must be computer literate using Microsoft software (i.e. Word, Excel... etc.). Knowledge of JDE and/or SAP is an asset.
• Excellent verbal and written communication skills. Bilingual in both English and French is preferred.
- KNOWLEDGE/EDUCATION
• Bachelor’s degree, or;
• Advanced degree.
• Minimum of 2 years of relevant experience, with a bachelor's degree, or;
• No minimum years of relevant experience, with an advanced degree.
SKILLS/COMPETENCIES
• Thorough understanding of ISO 13485 requirements, Good Manufacturing Practices (GMP) for Drugs regulations, Cells, Tissues and Organs (CTO), Canadian Medical Devices Regulations (CMDR) and Corporate Policies.
• Team player with very strong interpersonal skills.
• Strong problem solving and organizational skills.
• Detail oriented, accurate, and results driver.
• Works independently under limited supervision.
• Works in teams or projects and effectively interacts with other departments.
• Ability to manage multiple priorities in a fast-paced environment.
• Supports overall department needs as necessary.
• Must be computer literate using Microsoft software (i.e. Word, Excel... etc.). Knowledge of JDE and/or SAP is an asset.
• Excellent verbal and written communication skills. Bilingual in both English and French is preferred.
Nice to Have
SKILLS/COMPETENCIES
• Operations or Quality Management experience in a medical devices or pharmaceutical environment
• Skillful in formulating strategies, tactics and action plans to achieve results
• Strong focus on developing an organizational culture that fosters a Quality Mindset
• Ability to effectively influence key decision makers
• Ability to work well under pressure and maintain positive, enthusiastic attitude
• Solid knowledge of Canadian Good Manufacturing Practices (GMP), Cells, Tissues & Organs (CTO), Canadian Medical Devices Regulations (CMDR)
• Solid knowledge of Canadian Good Manufacturing Practices (GMP), Cells, Tissues & Organs (CTO), Canadian Medical Devices Regulations (CMDR)
Base Salary Range: 64k - 96k
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
