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QMS Manager

Start Date:ASAP

Duration of the Assignment: 1 year

Location: HTC

The QMS Manager is crucial for supporting the maintenance, enforcement, and management of a compliant and effective Quality Management System (QMS). This role ensures adherence to regulatory requirements for medical and non-medical devices and wellness products.

Key Responsibilities:

The QMS Manager is responsible for maintaining and enforcing a compliant QMS for Q&R processes and product quality. They will collaborate with Quality Managers across the organization, focusing on product development, launch, and maintenance of innovative products. This involves establishing transition plans, performing impact assessments, setting actionable goals, and ensuring the effective application of Q&R requirements.

Managing internal processes to facilitate effective communication between QMS, Philips IP&S, and Research is essential, ensuring compliance with evolving regulations and standards. The QMS Manager will coordinate internal and external audits to maintain QMS compliance and certification, establish proper document control procedures, assign training profiles, and ensure effective training administration.

Building a network within the company focused on Q&R topics is vital. This includes mentoring colleagues, presenting Q&R-related topics, supporting training administration, and contributing to training curriculum setup according to the Philips Business System. The QMS Manager will drive assigned Change Requests to closure, support corrective and preventative action processes, and execute the management review process.

Strategic Responsibilities:

The QMS Manager will formulate and implement long-range quality, regulatory, and compliance policies, leading organizational development and process improvement to meet strategic growth targets. This includes completing, certifying, and maintaining the Philips CTO Ventures QMS in collaboration with Quality Managers, emphasizing clinical research and innovative product development. Conducting post-market surveillance and ensuring compliance with applicable standards through internal audits, planning, and reporting is also essential.

Contributing to the continuous improvement of quality management processes and tracking key performance indicators related to these initiatives is necessary. Implementing and supporting data stewardship of clinical and other datasets within Research, ensuring proper documentation, and promoting their reuse within the company is also a key duty.

Participation and Advisory Roles:

The QMS Manager will actively participate in the Business Excellence department by presenting topics, engaging in discussions, and developing colleagues. They will advise on Q&R issues within the organization and maintain a network on Q&R topics aligned with business needs and key stakeholders.

Qualifications:

• Bachelor’s or Master’s degree in Science or Quality Engineering.
• 5-10 years of experience in a highly regulated industry, preferably medical devices.
• Experience as a Quality Manager, managing regulatory submissions (FDA, EU-MDD/MDR, CFDA), post-market surveillance, and QMS setup and maintenance.
• Ability to integrate compliance and ethics with operational excellence in an innovative environment.
• Strong understanding of and experience with software-dominant and AI-enabled solutions is highly preferred.
• Strong stakeholder management and relational skills for effective collaboration in a multi-stakeholder landscape.
• Excellent communication and presentation skills in English.
• Team player capable of elevating team performance.

Got Questions?Please get in touch with me at ritika.agarwala@yacht.nl