Quality Systems Spec
- 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
• Solid knowledge of Canadian Good Manufacturing Practices (GMP), Cells, Tissues & Organs (CTO), Canadian Medical Devices Regulations (CMDR)
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)