Senior Manager of Quality and Compliance
2 weeks ago
Exciting Opportunity at Merative
We are seeking a highly skilled Senior Manager of Quality and Compliance to join our dynamic team at 2105 Merge Canada Holdco Unlimited Liability Company. As a leading provider of data, analytics, and software for the health industry, we serve clients worldwide and are dedicated to driving real progress in health outcomes.
Position: Senior Manager, Quality & Continuous Improvement
Key Responsibilities:
- Quality Management Systems
- Develop and maintain an efficient Quality Management System to ensure compliance with regulations and industry standards.
- Lead internal and external audits to identify areas for improvement.
- Provide training and support to employees on QMS processes.
- Implement quality assurance processes such as Audit, CAPA, and Supplier Management.
- Continuous Improvement
- Promote a culture of excellence and collaboration within the organization.
- Drive initiatives to enhance the efficiency of the QMS.
- Collect and analyze quality metrics to monitor performance.
- Leadership
- Mentor and lead a high-performing team, setting clear performance expectations.
- Provide feedback, coaching, and recognition to team members.
Requirements:
- 7+ years of experience in healthcare technology or life sciences.
- Strong problem-solving and decision-making skills.
- Excellent interpersonal and communication skills.
- Bachelor's degree in a scientific or technical discipline.
Technical Skills:
- Knowledge of ISO13485, ISO14971, and IEC62304 standards.
- Familiarity with FDA and EU regulations.
- Understanding of Software as a Medical Device and agile development.
- Experience with technology applications like Jira and Confluence.
Work Environment:
- Office environment or remote work-from-home options available.
- Travel required approximately 10% of the time.
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