Philips
QMS Manager
Location: HTC, Eindhoven
Hours/week: 40
As the Quality Management Systems Manager, your primary focus will be on patient safety and quality, as well as the execution of our strategic initiatives. You will be responsible for the following key areas:
Patient Safety & Quality:
Foster a strong quality improvement mindset within the organization and enforce the current Quality Management System (QMS) resources.
Enhance our Corrective and Preventive Action (CAPA) process and capability, and utilize data analytics for continuous improvement.
Ensure compliance with audit requirements.
Strategy Execution:
Lead the QMS simplification strategy project, aligning with organizational transformation efforts.
Drive strong engagement to successfully deliver our strategic objectives.
To be successful in this role, we are looking for candidates who possess the following qualifications:
Bachelor's degree in a technical field with a minimum of 5 years of experience in QMS management, with a preference for experience in the medical industry.
Strong expertise in ISO 9001 and ISO 13485 standards.
Familiarity with global medical device regulations, requirements, and standards, including FDA's 21 CFR 820, EU Medical Device Directive (93/42/EEC), European Medical Device Regulation MDR 2017/745, ISO 13485, and MDSAP (including all member countries' regulations) is an advantage.
Proven ability to communicate effectively at all organizational levels.
Results-driven with the ability to manage competing priorities in a fast-paced environment.
Exceptional attention to detail and strong organization and prioritization skills.
Key Performance Indicators:
Resolution of QMS non-conformities and successful management of CAPA processes.
Implementation of QMS data analytic solutions for CAPA, audits, and other system areas, leading to continuous improvement.
Timely deployment of new QMS functionality within budget constraints.
Effective deployment of current system functionality across a large user group, enhancing compliance and efficiency.
Recognition by business leadership as a key resource for the business.
To be a part of the mission of advancing patient safety and quality in the medical industry while driving strategic initiatives to success, apply before 13th November. Do not hesitate to write me at Pallavi.mahadik_1@philips.com, in case of any questions. Thank you.