Senior Quality Systems Manager
il y a 3 semaines
As the Successful Sr Quality System Manager - Medtech - you will have the following responsibilities:
- Support the International organization to ensure an adequate and effective quality management system, supports the quality policy and sustains a quality
- Lead and manage Quality Systems activities including audit readiness.
- Lead and manage specifically the Document Management, Record Management, Training Management, CAPA, QNC, Field Action, and Supplier Quality Management quality systems in the region.
- Provide strategic and tactical vision and consultation toward the quality system development and implementation.
- Provide strategic and executive support to ensure alignment within the International Organization.
- Manage communications with the organization's Certification Body regarding all quality systems related activities and issues, including planning and responding to audits.
- Develop objectives and key performance indicators and tenaciously pursue
- Maintain state of the art knowledge in the quality related fields
- Leads the implementation, maintenance and training for relevant quality systems and tools, compliant to internal and external requirements, to meet business needs.
- Respond to customer needs in an accurate and timely fashion
- Provide leadership for quality system development, and ongoing process improvements.
- Initiate, develop and implement new quality concepts, tools and strategies to improve business systems, practices, and assure business objectives are met.
- Communicate project strategy and status to superiors and peers in a way that is timely, concise, accurate and responsive.
- Work in close cooperation with the Regulatory team.
As the Successful Sr Quality System Manager - Medtech - you will have the following requirements:
- At least a Bachelor's degree in a science, business, engineering, or related
- At least 10 years of related experience in the medical device or pharmaceutical industry managing quality systems.
- Analytical & detail oriented, team player.
- Excellent communication, problem solving and management skills are required.
- Proven Experience with CAPA, Change Management, Supplier Quality Assurance, and Risk Management is required.
- Position requires strong knowledge of MDD 93/42/EEC / MDR 2017/745, ISO 9001, and ISO 13485 requirements
- Ideally knowledge also on FDA, cGMP
- Experience in MS Office and Teams
- Excellent verbal and written English communication
- Experience with managing CE-marking and EU Regulatory Affairs
As the Successful Sr Quality System Manager - Medtech - you will have:
- A complete and attractive salary package in line with your experience (Base salary, Bonus, Company Car, Net allowances, Insurances, etc.)
- The chance to join a market leader with high people value
- Join a company that values and offers multiple career opportunity locally & globally
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