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QUALIFICATIONS AND JOB DESCRIPTION
NephroCan is a Canadian company dedicated to enhancing the quality of life for patients with End Stage Renal Disease (ESRD). As a trusted leader in the hemodialysis industry, we provide a comprehensive range of hemodialysis consumables and machinery. For over a decade, we have been at the forefront of research and development, delivering high-quality dialysis products to patients worldwide. Our mission is to continuously improve therapy methods and set new standards in the dialysis industry.
Position Overview
We are seeking a highly skilled and experienced Medical Device Production Manager to join our team. The successful candidate will be responsible for overseeing the production of medical devices in cleanroom environments, ensuring they meet the highest standards of quality, cost-efficiency, and regulatory compliance. This role requires a strategic thinker with strong leadership skills and a deep understanding of manufacturing processes, quality management systems, and product development in the medical device industry.
Key Responsibilities
• Strategic Leadership: Plan, implement, and follow the company’s strategies, policies, and action plans for medical device production, ensuring alignment with organizational goals.
• Production Management: Oversee the manufacturing of medical devices in cleanroom environments, ensuring they meet cost, time, quality, and quantity specifications.
• Quality Assurance: Manage and improve the quality management system (QMS) to ensure compliance with regulatory requirements, including ISO 13485:2016, MDD (Medical Device Directive), and MDR (Medical Device Regulation).
• Innovation & Development: Lead innovation, technology, and product development initiatives for new and existing medical devices.
• Team Leadership: Direct and coordinate the activities of the production team, including engineering, maintenance, and quality control.
• Regulatory Compliance: Ensure compliance with all applicable regulatory requirements for medical devices in the countries where NephroCan operates.
• Cleanroom Operations: Ensure that all production activities in cleanrooms adhere to strict cleanliness and contamination control standards.
• Risk Management: Implement risk management strategies for product design and development, ensuring the safety and efficacy of medical devices.
• Budget & Resource Management: Prepare and supervise annual budgets, raw material procurement, and workforce planning to meet production standards and needs.
Qualifications
• Education: University degree in Mechanical Engineering, Electrical Engineering, Medical Engineering, Chemistry, or a related field.
• Experience: Minimum of 8 years of experience in a similar role, preferably in the medical device or dialysis industry, with a strong background in cleanroom production environments.
Skills
- Strong organizational, decision-making, and problem-solving skills.
- In-depth knowledge of QMS standards, MDD, MDR, and CE Mark certification.
- Proficiency in risk management, quality assurance, and cleanroom operations.
- Excellent interpersonal and multicultural communication skills.
- Advanced proficiency in MS Office, particularly Word and Excel.
Language: High intermediate level of English (written and spoken).
What We Offer
• Competitive Salary: We offer a competitive salary package that reflects your experience and expertise.
• Extended Health Benefits: Comprehensive health benefits to support your well-being.
• Positive Workplace Culture: At NephroCan, we pride ourselves on fostering a collaborative, inclusive, and supportive work environment where every team member is valued.
• Professional Growth: Opportunities for continuous learning and development to help you advance in your career.
Why Join NephroCan?
• Be part of a Canadian company that is making a real difference in the lives of patients with ESRD.
• Work in a dynamic and innovative environment with opportunities for professional growth.
• Collaborate with a team of passionate professionals dedicated to improving dialysis therapy worldwide.