Vacature Operator allround / technician

Ons bedrijf
Polyganics ontwikkelt, produceert en verkoopt wereldwijd biologisch afbreekbare medische producten. Onze producten worden gemaakt van bio-afbreekbare synthetische polymeren. Ze worden door het lichaam afgebroken, waardoor er na een operatie in een later stadium geen chirurgische ingreep meer nodig is om ze te verwijderen. Dat maakt onze producten zeer patiëntvriendelijk, veilig en kostenbesparend.

Wat houdt deze baan in?
De Operator allround is onderdeel van een van de teams binnen de afdeling Operations, maar in deze functie ben je binnen alle teams inzetbaar. Dat betekent dat je in het lab werkt en daarnaast als dat nodig is ook in een van de cleanrooms of bij verpakking.

Jouw taken en verantwoordelijkheden zijn onder andere:
– het produceren van halffabricaten voor medische toepassingen
– het produceren van bio afbreekbare medisch producten bij andere productieprocessen en ondersteunen van testen door R&D
– regelmatig werken in een cleanroom

Wie zoeken wij?
Een leuke, open collega die goed kan samenwerken in een team.
Je hebt:
– minimaal 5 jaar ervaring als Operator bij een medical device of farmaceutische bedrijf
– bij voorkeur ervaring met het werken met polymeren
– bij voorkeur een afgeronde MBO opleiding chemie of ervaring op dat niveau
– je kunt zelfstandig werken, bent nauwkeurig, resultaatgericht en boven alles een plezierige collega

Geïnteresseerd?
Wil je deel uitmaken van een leuke en groeiende organisatie waar ruimte is voor eigen initiatief en ontwikkeling? Dan nodigen wij je uit te solliciteren via hrm@polyganics.com.

Voor meer informatie kun je bellen met Jan Disbergen 050 588 65 88 of met Henne Barkema (HR) 06 520 61 635.
Vacature Operator 2021

Headhunters en (uitzend)bureaus verzoeken wij uitdrukkelijk niet te reageren op deze vacature.

Vacancy Manufacturing engineer

Our company
Polyganics is an innovative medical technology company. We develop, manufacture and commercialize worldwide, innovative bioresorbable devices to facilitate tissue repair and regeneration after surgery. We adapt our versatile polymers for different clinical applications, improving surgical outcome and patient recovery.


The job

As one of our Manufacturing engineers you will be improving our processes and equipment. You will work on  trouble shooting, up-scaling, improving and validation of existing production lines. As we are a medical device company this includes collecting and recording data and writing solid protocols and reports.
Part of the job will be to investigate plant- or process-improvement opportunities. These improvement projects are related to different aspects, e.g. safety, quality, capacity and efficiency.

 
Your profile
We are looking for a team player who will thrive in an entrepreneurial and technology driven business environment.
You have a BSc/MSc degree in chemical/process engineering or equivalent. Five years or more work experience in the manufacturing or process industry / medical device industry and knowledge of GMP / ISO 13485 is preferred.
You have worked with polymers before. Experience with Lean Six Sigma or statistics is an important asset.
This full-time position demands a high level of interpersonal skills, robust analytical skills, proactivity, personal integrity and excellent written communication skills in English.

Our offer
We offer a responsible, independent and challenging position in a growing organization with the opportunity to develop yourself.
Polyganics has a professional but informal working environment and a pleasant work atmosphere. We offer a competitive salary, good secondary benefits and support your efforts to improve yourself.

Would you like more information?
Please contact Harm de Vries, Manager +31 (0)50 588 6588 or Henne Barkema (HR) +31 (0)6 52 0616 35.

You can send your resume with a short motivation to hrm@polyganics.com

Vacancy manufacturing engineer 2021

Recruiters and headhunters need not apply.

Vacancy Regulatory Affairs Associate

Our company

Polyganics is an innovative medical technology company. We develop, manufacture and commercialize worldwide, innovative bioresorbable devices to facilitate tissue repair and regeneration after surgery. We adapt our versatile polymers for different clinical applications, improving surgical outcome and patient recovery.

The job

As Regulatory affairs associate you will prepare submissions (CE, IDE, PMA) of high-risk medical devices. You manage preparation of new regulatory documents and dossiers to enable new products to be launched and maintained in the market, with the correct alignment and compliance to regulations. You provide support with change notifications and initiate and maintain technical files and registrations. You perform vigilance / medical device reporting.

Your profile

– We are looking for an associate who maintains current knowledge of medical device regulations, guidance and standards applicable to product submissions.

– You understand and have working knowledge of FDA medical device regulations, European Medical Device Directives/Regulation, and/or other global regulations. – You demonstrated working knowledge of scientific principles.

– You have a Bachelor or Master degree in Regulatory Affairs or related discipline and up to three years work experience in a similar function. This position demands a high level of interpersonal skills, personal integrity and excellent written communication skills in English.

Our offer

We offer a responsible, independent and challenging position in a growing organization with the opportunity to develop yourself. Polyganics has a professional but informal working environment and a pleasant work atmosphere.

We offer a competitive salary, good secondary benefits and support your efforts to improve yourself.

Would you like more information? Please contact Ms. Betty IJmker, director QA/RA at+31 (0)50 588 65 88 or Ms. Henne Barkema (HR) at +31 (0)6 520 61 635.

You can send your resume with a short motivation to hrm@polyganics.com

Vacancy RA Associate 2021

 

Recruiters and headhunters need not apply.