Vacancy Process Development Engineer

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Our company

Polyganics is an innovative, privately held medical technology company bringing to market unique bioresorbable devices to facilitate tissue repair and regeneration after surgery. From its ISO 13485-certified manufacturing facility, products are distributed to customers worldwide. Polyganics has recently moved to a new facility at the Zernike Campus, Groningen, which houses its headquarters, state-of-the-art research laboratories and manufacturing and packaging facilities. More information: www.polyganics.com

The job

Polyganics is looking for a Process Development Engineer. As a Process Development Engineer, you will be focusing on the design of production processes and you will support the transfer from prototype to production. You will work in a team of Engineers within the R&PD department, in a cross functional environment and you will report to the Manager Engineering.

Key responsibilities

  • Design and development of new production processes
  • Documentation and qualification of production processes
  • Ensuring that processes and documentation comply with applicable standards and regulations (ISO, GMP, et all)
  • Contributions to projects
  • Initiating technological innovations
  • Assessing safety and process risks and addressing associated controls measures e,g, adjustments of the process or equipment
  • Setting specifications for new equipment

Your profile

  • A Bachelor or Master degree in Chemical Engineering or Process Technology
  • Knowledge of and experience with automated systems
  • Knowledge of standards, guidelines and norms for production of medical devices and or pharma
  • Excellent written and oral communication in English and Dutch
  • Knowledge of polymer chemistry is an advantage
  • Critical, conceptual and analytical thinker
  • Able to see new possibilities
  • Attention to detail and quality
  • Self-starter and team-player with good interpersonal skills

Our offer
We offer a dynamic 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 and good secondary benefits.

Would you like more information?

Please contact Mrs. Marleen Schoonen (HR) +31-50-588 6 588

You can send your application to hrm@polyganics.com.

Headhunters and recruiters need not apply.

 

Manager Backoffice and Customer Support, Groningen – office based

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Our company
Polyganics is an innovative, privately-held medical technology company that develops, produces and markets unique bioresorbable devices. Our products facilitate tissue repair and regeneration after surgery. From our ISO 13485-certified state-of-the-art research laboratories and manufacturing and packaging facilities, products are distributed to customers worldwide. More information: www.polyganics.com

The job
You will be responsible for customer support and will lead Polyganics’ back office and managerial support team. In addition, you will directly interact with visitors of Polyganics’ office in Groningen and, from this location, with key customers worldwide. You will report to the Chief Operational Officer and closely work with the Sales Director and Director Marketing and Business Development.

Key responsibilities
* Ensure customer-oriented service
* Make sure that contract deliverables and deadlines are adequately met
* Support in sales and marketing processes; such as control of marketing material, document control, monitoring of orders and tracking of shipments
* Coordinate and lead all office management activities, ensuring that office management operates smoothly and efficiently
* Overseeing management support staff, receiving and directing visitors, and handling or delegating basic office management tasks.

Your profile
* Bachelor degree
* Demonstrated experience with customer support & service and preferably with office management as well
* Excellent organizational skills and interpersonal skills, strong attention to detail and the ability to set priorities within a dynamic environment
* Excellent verbal and writing communication skills, both in Dutch and English
* Ability to manage your workload and supervise others concurrently
* Essential social media and marketing experience
* Experience in the medical device industry, experience with SAP and proficiency in the German language (oral and written) are an asset.


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 and good secondary benefits.

Would you like more information?
Please contact Mrs. Henne Barkema (HR) +31 (0)6 52 0616 35.
You can send your resume with a short motivation to hrm@polyganics.com.

Manager Backoffice and Customer Service

Recruiters and headhunters need not apply.

Vacature Operator allround / technician

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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

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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

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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.