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Herakles Pharma

Quality Assurance Engineer- interim/Permanent

Functiegroep: Quality Assurance & Compliance
Locatie:Groningen
Procedure: Detachering
Vacature ID:#729
Publicatiedatum:08-02-2019

Quality Assurance Engineer- interim/Permanent

De organisatie

Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. At Johnson & Johnson every colleague makes a vital difference. Our people take pride in improving people’s health around the world. Each day, they make life better by going for high quality and continuous innovation. While doing so, they get the chance to grow their competences and take initiatives. All of this in an international, value-driven group that cares for the wellbeing of its people. A group that contributes to the quality of life as a global partner in healthcare. Johnson & Johnson is at the forefront of a new era in total healthcare solutions. J&J Surgical Vision in Groningen is the Center of Excellence for the development of innovative solutions for the surgical ophthalmic market, mainly intraocular lenses (IOLs). The site is responsible for the design and manufacture of these products. Do you want to contribute on the edge of quality, driving product and new technology development from a Quality perspective? Do you have affinity with medical devices, like to work in an agile and ambitious environment? Our Quality Assurance department is currently looking for two new quality professionals to strengthen our team.

De functie

As a Senior Quality Assurance Engineer you have a good working knowledge of the applicable regulations regarding the development and production of medical devices, in line with the Medical Device Directive 93/42/EEC, 21CFR Part 820 and ISO 13485 and ISO 14971. In this role you contribute directly to product development projects. These are either projects to develop a new Intraocular Lens, or to further develop technology to mass-produce the Intraocular Lenses. You have a close loop approach to quality, like working in teams and projects, are result driven, while having a pragmatic and critical attitude that ensures that the site is in compliance and delivers products of high quality.
Main tasks for the function as a Quality Assurance Engineer- interim/Permanent:

  • You are the key Quality representative in multidisciplinary team to support new product development projects;
  • You ensure in these project that all performance, quality and compliance reviews are done in a timely and compliant manner and followed up as needed;
  • Within development projects you are the process owner of risk management and you set up risk management documentation (FMEA) with a multidisciplinary team;
  • You ensure that the change control procedures are correctly applied, and you review and approve project and Quality documentation;
  • You have working knowledge of process and product validation and ensure correct application via proactive support, and review and approval of documentation;
  • You support, perform and assess statistical analyzes and support in the implementation of statistical process control techniques, sampling schemes and other quality techniques;
  • You communicate recent developments about Standards and cGMP in your area of work;
  • You identify critical areas for improvement and prioritize and execute the quality improvements initiatives resulting from this. As needed, you perform or support non-conformance / CAPA root cause investigations, defining action plans and drives these to completion;
  • You are responsible for inspection readiness of the projects in scope of your work, and act as an Subject Matter Expert during internal and external audits (e.g. Notified Body or FDA);
  • You escalate any quality or compliance issues to upper management;
  • You maintain a relevant network of contacts with quality and other expertise within JJSV and other J&J companies, but also with other MDD companies and professional associations, which will allow you to identify best practices for the work.

Het profiel

Qualifications for the function as a Quality Assurance Engineer- interim/Permanent.
We have an experienced team, a challenging work environment and are among the absolute forerunner in the IOL market. As a future colleague, we want you to match within the following criteria:

  • Minimum of five years of relevant work experience preferably in the pharmaceutical or medical device industry;
  • Master of Science degree (technical, life science or related);
  • Working knowledge of Risk Management, Change Control, Validation of products/equipment/ processes, Statistics;
  • Knowledge of relevant Medical Device regulations (GMP, MDD, QSR CFR 820, ISO 13485, ISO 14971);
  • Self-starter, result driven, able to function independently as well as in a team;
  • Able to work towards sound solutions in complex or seemingly conflicting situations;
  • Flexibility and accuracy;
  • Good communicative skills, excellent command of the English language and preferably the Dutch language;
  • Knowledge of MS Office.

Het aanbod

This position is a temporary role awaiting a permanent fill. It is also possible to start temporary and get a J&J contract after 6 months.

Inlichtingen bij

More information about the Quality Assurance Engineer? Please contact Leonie Koomen at Leonie@heraklespharma.nl or 06-10518323.

Meer informatie
Leonie Koomen Recruiter leonie@heraklespharma.nl 06-10518323