Quality Assurance Engineer

Driven quality engineer focused on business development.
Fulltime / 40 uur / 1fte

Quality Assurance Engineer

The challenge

Polyganics’ bioresorbable products have a major impact on tissue repair. Medical devices are subject to strict laws and regulations. With your knowledge of regulations within the (medical) industry (such as FDA, Europe, ASTM and ISO requirements), you ensure that used materials, processes and production techniques deliver high-quality and reliable products. You develop production control plans, dashboards and trend files for production and quality control processes. You also manage work completed by external suppliers to ensure products meet PG procedures and quality standards. You provide guidance to all colleagues on Lean Six Sigma principles (sampling, acceptance criteria, DOE, statistical process control, Root Cause Analysis, FMEA, control charts, capacity analysis).

You support engineers and production/process engineers in process characterization activities and provide input for protocols and reports.
You guarantee the output and operation of the quality system. This includes supporting production/process engineers in process characterization activities and providing input for protocols and reports. As well as evaluation of design and/or production process changes for their impact on DHF. You will lead and implement activities to close any gaps, such as additional verification tests or updates to risk documentation. You support the procurement department from the very beginning with advice on which suppliers are (can be) admitted.

You will ultimately be expected to look beyond standard processes, making everything predictable and controllable, where possible with another stroke of digitization and other tooling. For this, ‘out of the box’ thinking is a must. Among other things, you will also have to deal with cost control, risk management, quality awareness and quality improvement. By standardizing and making quality processes more efficient, you are in full control. Setting up new systems and implementing improvement actions is a challenge in which you get a lot of freedom. The combination of a high degree of independence and support from your team ensures that Polyganics continues to develop itself and its products.

You will work in a team of 7 subject specialists (Regulator Specialist, Quality Technicians, Quality Engineer and a Quality Specialist). Due to Polyganics’ rapid growth, we are looking for a Quality Assurance Engineer to join this team. You will report directly to the Director QA/RA. As you read, there is a wide and diverse range of tasks waiting to be picked up by you at Polyganics!

The ideal profile

  • You have a university working and thinking level obtained through a relevant BSc degree in a technical field or an MSc degree in (medical) industry, chemistry or pharma.
  • You have at least 5 years’ work experience as a QA engineer or a comparable role within the medical industry, food & feed, pharma or chemistry.
  • You are a stress-resistant team player who thrives in an entrepreneurial and technology-driven environment.
  • You have an excellent command of the Dutch and English language in both word and writing.
  • You have a Lean Sigma certification / Black belt in process excellence.
  • You have a clear understanding of FDA, MDR and ISO requirements.
  • You have knowledge of and experience with production controls, risk assessment, improvement methods and techniques and statistics.

About Polyganics

From the Zernike Science Park (Groningen), Polyganics focuses on biomedical (resorbable) devices and tools which transform and facilitate patient recovery. The rapidly growing company is gearing up for its next professionalization drive, especially now that Collagen Matrix Inc. of the United States has acquired all shares by the end of 2022. Polyganics supports Collagen’s vision to be a world leader in regenerative medicine through the development of bioresorbable solutions of tissue and bone repair. A new milestone in the existence of the University of Groningen spin-off founded in 1999.

Polyganics has been researching biodegradable medical implants for more than 20 years. Polyganics has established a strong position internationally in this field, particularly through the successful development and commercialization of polymer products with an application in ear, nose and throat surgery, peripheral nerve repair and neurosurgery. These products are sold worldwide. Polyganics is located in new state-of-the-art premises on the Zernike Campus, making it ready for further growth. For more information, please visit www.polyganics.com.

Polyganics offers a responsible independent and challenging position in a growing organization with plenty of opportunities to develop yourself. Polyganics has a professional but informal working environment and a pleasant working atmosphere. It offers a (more than) competitive salary, good fringe benefits (a nearly non-contributory pension) and they support your efforts to improve yourself.

Interested in Polyganics in Groningen?

Does it appeal to you and do you meet the required profile? Then we are very interested in your CV and motivation! ASBR YouManagement exclusively guides Polyganics through the entire process. From there you can apply (confidentially) to ASBR YouManagement, Heleen Wielinga. For questions or an explanation, please call +31(0)88 1260440 or email h.wielinga@asbr.nl.