qms manager (17362) in eindhoven

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job details

eindhoven, noord-brabant
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Vacature omschrijving

Support PInS QMS team to define and implement new QMS 

Period = 6 months (period extension possible) 

Site = HTC 

Your Challenge 
You will be an integral member of the project team in charge of developing a new Quality Management System (QMS) within Philips Innovation Services (PInS). 
Your personal challenge will be to pro-actively support the QMS project team and the PInS organization with all kinds of actions related to the definition and implementation of the new QMS. 

We welcome you to a challenging, innovative environment with great opportunities for you to explore. 

Philips is driven by their mission to improve the lives of 3 billion people per year by 2025, and every day they move closer to achieving their goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to their employees who share their passion for improving lives, they are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy and respiratory care. They enable their employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs.


Competences and Experience 
In depth knowledge and understanding of ISO 9001:2015, ISO 13485:2016 and ISO 14971:2016 amongst other relevant standards, rules and regulations. 
Highly experienced writing and reviewing processes, procedures and work instructions in close communication with subject matter experts (SME’s) and other relevant stakeholders. 
Good knowledge of and insight in QMS architecture and its document structure. 

Essential Duties and Responsibilities: 
You will be responsible for effective and efficient support on reviewing the currently available QMS documents against the revised QMS architecture and various gap assessments performed earlier this year. You will support the team in driving the gap-closing actions to timely completion. 

In addition, you will create and review presentations and newsletters as well as guiding and coaching the relevant stakeholders like Business Process Owners (BPO’s) and Process Owners (PO’s). 

The support of day-to-day Quality related activities such as actioning on CAPAs, complaints and other Quality and QMS related tasks as assigned. 

Specifically, this may include [but not limited to]: 
 Assessing the existing business processes for consistency with the standards and identification of required improvements, 
 Review process associated documentation, join the relevant discussions to arrive at a fully compliant QMS, 
 Support Business Process Owners at various levels in the organization to establish revised and updated procedures and any other documentation for assigned QMS processes as per the guidance of the project team, 
 Assist the QMS project team and the relevant departments and groups with development and implementation of action plans to improve overall ISO 
compliance and quality results, closing the gaps of the ISO 13485:2016 compliance gap analysis and other business programs that may affect the QMS, 
 Support the deployment of revised and/or new QMS documents in conjunction with the respective process owners, 
 Perform internal audits and other related duties as assigned. 

Personal Skills and Abilities: 

 Pro-active, “Hands-on” supporting mindset. 
 Strong communication, interpersonal, and organizational skills. 
 Ability to conceptualize, analyze, plan and organize. 
 Reasoning skills for problem identification and resolution. 
 Computer literate; proficient in utilizing MS Office Suite, MS Project amongst others. 
 Competent in problem solving, team building, planning and decision making.