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Quality Assurance Officer

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Zuid-Holland
Oud Beijerland

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HBO/WO

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Quality Assurance Officer

Van16-09-2019 LocatieOud Beijerland Urenn.v.t. OpleidingHBO/WO

Quality Assurance Officer –Medeco B.V.

Our people are the heart of Mediq: they are the ones who improve our future by taking that extra step for the patient. With more than 4,000 motivated colleagues, we continue to work on improving the quality of life for millions of people. At this moment, we are already the homecare market leader in 12 countries within Europe, and we have the ambition to develop into one of the largest international players. We do this by starting each day with the question: how can we provide care that is even better and more affordable? That is exactly what we mean when we say: committed to your care.

Mediq has an ambitious strategy to provide better and affordable care to patients in a dynamic health care environment. Our Mediq own brands assortment and development has been defined as one of the value drivers for Mediq and therefore part of the corporate growth strategy. Product quality is essential to secure the reputation of, and trust in, Mediq own brands products. To ensure unmatched quality and value to customers and patients, Medeco BV has implemented a full annex II certification and related QA and RA department. Medeco BV is part of Mediq.

We are currently looking for a Quality Assurance Officer at Medeco BV. We are responsible for managing and producing the Mediq Own Brands assortment which currently includes over 1,000 products. The team is based in Oud-Beijerland, the Netherlands and currently has its own dedicated team of approx. 20 full-time members. Medeco BV is a dynamic and ambitious international organization that, with its distinctive function, is prepared to invest in your development. We offer a pleasant informal working environment with open and transparent internal communication lines.

Where are you coming from?

Qualifications, experience and skills

The successful candidate will have extensive knowledge and at least 2 years proven experience in managing quality systems, quality improvement and quality measurement standards. Preferably within a global private label context. Academic grade or work- and intellectual level in Quality Assurance and a background or related education in life-sciences is required. Experience in the medical device/disposable industry is strongly preferred. Fluency in English is also required as well as strong project management skills/experience.

 

Next to that the candidate has the following specific knowledge and expertise:

Awareness of law’s, regulations and standards (ISO-13485, ISO 9001, MDD / MDR etc.) for

The product assortment available within the group (medical devices, personal protection).

Manufacturing processes.

Knowledge and expertise with quality systems and their certification dynamics. Trend monitoring, and reporting for compliance.

Experience with Auditing and CAPA, vigilance and related notification aspects.

Knowledge and educational skil for getting regulatory aspects implemented in an organisation

 

 

Where are you heading?

Your role

The Quality Asurance Officer is responsible for the defining and execution of the quality management system of Mediq Medeco B.V. and reports to the Head of Quality Management He or she is responsible for Collecting, registering, maintaining and distributing QMS documents for private label product production in accordance with applicable laws and regulations.

 

Next to that the QA Officer will review and update procedures for self-certification (i.e. class 1 medical devices) and certification in cooperation with a Notified body (i.e. class Is medical devices). Monitoring external changes to the related standards and assess impact for Medeco B.V. also related to FSMP and CPNP is also a main aspect of the job. He or she is a gatekeeper in vigilance processes and complaint management.

The responsible person also supports the auditing of the Medeco B.V. quality system based on internal and external requirements and developments, dealing with internal stakeholders with respect to the required quality system for products.

 

Which skills can you apply?

The successful candidate will be comfortable working at pace, in a highly complex commercial environment and dealing with ambiguity. He/she will be part of the QA/RA organization and has the ability to provide high services to stakeholders. Must have a proven track record of the ability to influence others. Must have the ability to work methodically and systematically with attention to detail and manage multiple tasks at once. Is able to communicate at different levels internally as well as externally. Needs to have strong analytical skills as well as strong decision-making and problem solving skills. Must have a good sense of urgency and is deadline-oriented. Must be able to work independently within a team environment.

 

What environment you will work in?

An international environment within the health care industry. Mediq is present in 14 countries.

Our offer?

A pleasant, informal and international work environment, a result driven team and a lot of personal growth opportunities. A good salary and a competitive remuneration package.

 

Apply for this job?

If you wish to apply, please click here. For more information, you can contact Johan Verhagen (Head of Quality Management Mediq Medeco) via johan.verhagen@mediq.com.

   
Vacature delen    
08-01-2020 n.v.t. n.v.t. n.v.t.
24-12-2019 Leek n.v.t. HBO