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Senior Quality Assurance Engineer

2019-02-07 CLS Services | Groningen | WO / MBA | Fulltime | Sluit 2019-04-08

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 a new quality ...

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Johnson & Johnson Surgical Vision, we are searching for a Senior Quality Assurance Engineer.

Company profile
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 well-being 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.

Department
Johnson & Johnson Vision is committed to improving and restoring sight for patients world-wide. 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.


Job description
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 a new quality professional to strengthen our team.

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 responsibilities:

  • You are the key Quality representative in a multidisciplinary team to support new product development projects;
  • You ensure 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 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 analyses 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 prioritise 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 drive these to completion;
  • You are responsible for inspection readiness of your projects, and act as a Subject Matter Expert during internal and external audits (e.g. Notified Body or FDA).


Who we're looking for
The ideal candidate has an academic background (technical, life science or related) with at least 5 years of relevant working experience in the pharmaceutical of medical device industry. You have working knowledge of Risk Management, Change Control, Validation of products/equipment/ processes and statistics. Next to that, you have knowledge relevant Medical Device regulations (GMP, MDD, QSR CFR 820, ISO 13485, ISO 14971). You are able to work towards sound solutions in complex or seemingly conflicting situations.
The candidate fit for the job is accurate, a self starter, result driven and can work both independent as well as in a team. In addition, you are an excellent communicator in English and preferably also in Dutch.

Additional vacancy information
Reference: A1900014
Contract: Temporary contract with CLS Services
Education: WO/MSc.
Terms: Full time preferred, 32 hours is discussable. This could be a temp-to-perm opportunity or a 6 month project.
Contactperson: Aniek Vugts
Phone: +31 (0)88 22 77 555



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