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 Polyganics’
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,
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 the 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.
a Regenity Biosciences company.
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 our
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
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 device industry preferably, or food,
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.