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Senior RA/QA Officer Medical Devices (ISO 13485)

Meer details
Match criteria
Regio
  • Utrecht
Gewenst aantal uren
  • 32 uur
  • ,
  • 36 - 40 uur
Opleidingsniveau
  • HLO/BSc
  • ,
  • MSc
Functiegroep
  • Quality Assurances QA
Dienstverband
  • Vast

What are you going to do?

For an international and highly specialised company within the field of Medical Devices we seek an experienced Senior Regularoy Affairs / Quality Assurance Officer. The company is market leader and produces Medical Devices, specifically non-invasive instruments. They are rapidly expanding and have headquarters in the USA and UK and are looking to expand their product to the European market. Utrecht will be the epicentre for severall services including QA/RA throughout Europe.

For this expansion we are looking for a Senior RA/QA Specialist who is able to operate autonomously and will be the responsible person for a wide range of QA related tasks. Because of the fast-growing nature you will be in charge of implementing the quality standards (ISO 13485, ISO 9001, GMP) from start to finish and you will supervise the entire process.
Moreover, you will monitor these set quality guidelines, coordinate and optimize these procedures and monitor the supply chair including external suppliers (auditing). As an experienced professional you will be able to apply your knowledge and improve all internal processes regarding ISO 13485 and/or MDR (Medical Device Regulation) as the driving force for activities related to these guidelines. Furthermore, you will be involved in reviewing and approving quality documents, SOPs, CAPA's and (internal and external) audits.

Because they are growing fast there is a good scope for career development and manage other Regulatory/Quality Assurance personnel.

What are we looking for in Senior RA/QA Officer Medical Devices (ISO 13485)?

For this position we are looking for the following profile:
  • Bachelor's degree or Master's degree in Pharmaceutical Sciences, Biomedical Science or related
  • At least 5 years of experience within RA / QA.
  • Experience with Medical Devices, ISO 13485, GMP and MDR
  • Good knowledge of CAPA's, audits and document review.
  • Strong written and verbal communication skills
  • Excellent organizational skills

Wat kun je verwachten van het bedrijf?

The company is growing rapidly and is looking for experienced personell. They offer ample opportunity for growth within this role and within the company.

What do they offer Senior RA/QA Officer Medical Devices (ISO 13485)?

  • Salary: up to €7000,- per month depending on experience level
  • The salary level is highly competative, with good benefits
  • Permanent contract
  • 32-40 hours per week


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Locatie

Utrecht

Publicatiedatum

13.01.2022

Contactpersoon

Dirk Burgmans

Medewerkers
Dirk Burgmans
Werk telefoon: +31 20 3032 120
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