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Over de functie
Support PInS QMS team to define and implement new QMS
Period = 6 months (period extension possible)
Site = HTC
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.
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.
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.
At YACHT we will offer you a competitive benefits package in line with the seniority of the position.
You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Sciences industry.
You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.Yacht is a contractor for highly educated professionals (BSc, MSc, or PhD) who’ll work on site and innovate together with our customers to find smart solutions. Being part of the world wide Randstad Group we have an extensive network of clients and professionals.
Working as a high tech professional within Yacht means you will work on interesting and challenging long term projects. Our Brainport region is considered to be the smartest region in the world! We cooperate with high tech companies that work on the cutting edge of technology. To give you an example of our portfolio: ASML, Philips Healthcare, Philips Lighting, Philips Research, TNO, FEI company, DAF, VDL ETG, Océ and many others.
Voor meer informatie neem je contact op met Lotte den Otter via telefoonnummer 06-22869400
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.