Oorspronkelijke vacature omschrijving:
Location: Maastricht-Airport Contract: 40 hours Education: Bachelor - University
Technomed is looking for new talent!
Quality Assurance Engineer
Location: Maastricht-Airport
Who are we:
Technomed Engineering BV is part of the international Welcony group. Welcony is a global leader in neurotechnology supporting thousands of research laboratories, clinics, hospitals and universities focusing on mental health, brain disorders, cognitive neuroscience and neuromonitoring. We have four brands and one mission: ‘Bring to market the best non- and minimally invasive neurotechnology for researchers, clinicians and patients’. The Key brands and technologies include: Magstim - Transcranial Magnetic Stimulation (TMS), MagstimEGi - High-Density EEG, Technomed - Clinical Neurophysiology and Neurosign - Nerve Integrity Monitoring. For more information about our Welcony brands, please visit our website Technomed Europe is specialised in medical device accessories with headquarters in Maastricht-Airport and its own production facility in Indonesia.
Position Summary:
As a Quality assurance and regulatory affairs team member you will be supporting the R & D and operation departments for the development of new products and line extension, the production processes development and; the control and quality inspection tests development and improvement for raw material and finished products to ensure product performance, safety and reliability.
Roles and Responsibilities:
- You act as the quality assurance representative in cross functional project team where you ensure each project is run according our QMS with a particular focus on design control, risk management and document control.
- You are making sure all quality deliverables are adequately planned, executed and documented; you contribute to or create detailed, comprehensive and well-structured test plans.
- You are directly involved in developing/writing and reviewing requirements, specifications and technical design documents including V & V to provide timely and meaningful feedback.
- You are also contributing to non-conformities and CAPA investigation, providing test plans, data review and approval.
- As quality inspector back up; you are involved in occasionally executing quality inspection test according established methods; and you will be improving existing methods.
- You are a partner for our internal stakeholders. You exchange information on quality perspective on the most diverse (customer) projects in order to meet requirements.
- You hang on with your claws and teeth in projects related to good document control, training management, internal auditing.
- Technomed is already aware of quality and regulatory requirements. But you can figure out how things can get even better here. You make contribution to QMS by improving existing QMS procedure or writing new QMS procedure if required;
Make a long story short, do you wonder how you explain this to your friend and family? Then say: “Well, I ensure that all medical products Technomed produces are of high quality and safe for you and your family when used in hospitals all over the world.”
How do you handle this?
- As a Quality Assurance Engineer, you are constantly busy with…. Getting the quality of data and documents to the highest needed level. Technical documents and information are your second nature and part of your Technomed life.
- You collect and analyse data to make decent and well-founded technical document that can be share with customer, regulatory authorities and notified body. You are involved in audit from any of these organisations.
- You are able to handle complexity, handling different concurrent tasks and prioritise your own work, and have the flexibility to adapt quickly to new priorities
Who are you?
- You have at least three years expertise in design control and preferably have a, engineering or scientific Bachelor’s degree or experience in life sciences, (bio)medical, chemistry, pharmacy or other related expertise.
- You have demonstrable working experience with Design control according ISO 13485 (2016), risk management according ISO 14971 and Usability according IEC 62366.
- You know how to write specification requirements, set control limits and complete trend analyses, with applicable statistical methods.
- English? YES! Dutch? Dat is handig! You make an impression with your English either orally and in writing.
- Your smooth communication style gives you the advantage that you can level with all kinds of individuals and you are a team player in heart and soul.
- You learn quickly, are eager to develop and take proactivity of paramount importance.
- You enjoy helping the organisation to level up. Offering added value: that is what you live for!
Why would you work for us?
You will be part of the growing and ambitious environment of the Welcony group. A dynamic organization in full expansion, internationally oriented and with an absolute drive to maintain mentality and atmosphere of a small organization. We value a hands-on approach and allow you to excel, develop, create and implement your own expert knowledge that can be converted to the best results. We support talents to further develop their competences. We are a down-to-earth, results driven organization with short lines of communication and quick decision making. We have an ambition and passion to become a strong leader in the medical world. We want to realize this with the best people and breakthrough innovations.
Interested?
Please send your CV and motivation letter by submitting your application by using our Online Application Form For more information about the vacancy, please contact Monique Berwaer, Manager QA&RA, mberwaer@technomed.nl for information about our procedure contact Jefte Erens, Global HR Director, jerens@technomed.nl
Acquisition to this vacancy is not appreciated.
Oorspronkelijke vacature omschrijving:
Location: Maastricht-Airport Contract: 40 hours Education: Bachelor - University
Technomed is looking for new talent!
Quality Assurance Engineer
Location: Maastricht-Airport
Who are we:
Technomed Engineering BV is part of the international Welcony group. Welcony is a global leader in neurotechnology supporting thousands of research laboratories, clinics, hospitals and universities focusing on mental health, brain disorders, cognitive neuroscience and neuromonitoring. We have four brands and one mission: ‘Bring to market the best non- and minimally invasive neurotechnology for researchers, clinicians and patients’. The Key brands and technologies include: Magstim - Transcranial Magnetic Stimulation (TMS), MagstimEGi - High-Density EEG, Technomed - Clinical Neurophysiology and Neurosign - Nerve Integrity Monitoring. For more information about our Welcony brands, please visit our website Technomed Europe is specialised in medical device accessories with headquarters in Maastricht-Airport and its own production facility in Indonesia.
Position Summary:
As a Quality assurance and regulatory affairs team member you will be supporting the R & D and operation departments for the development of new products and line extension, the production processes development and; the control and quality inspection tests development and improvement for raw material and finished products to ensure product performance, safety and reliability.
Roles and Responsibilities:
- You act as the quality assurance representative in cross functional project team where you ensure each project is run according our QMS with a particular focus on design control, risk management and document control.
- You are making sure all quality deliverables are adequately planned, executed and documented; you contribute to or create detailed, comprehensive and well-structured test plans.
- You are directly involved in developing/writing and reviewing requirements, specifications and technical design documents including V & V to provide timely and meaningful feedback.
- You are also contributing to non-conformities and CAPA investigation, providing test plans, data review and approval.
- As quality inspector back up; you are involved in occasionally executing quality inspection test according established methods; and you will be improving existing methods.
- You are a partner for our internal stakeholders. You exchange information on quality perspective on the most diverse (customer) projects in order to meet requirements.
- You hang on with your claws and teeth in projects related to good document control, training management, internal auditing.
- Technomed is already aware of quality and regulatory requirements. But you can figure out how things can get even better here. You make contribution to QMS by improving existing QMS procedure or writing new QMS procedure if required;
Make a long story short, do you wonder how you explain this to your friend and family? Then say: “Well, I ensure that all medical products Technomed produces are of high quality and safe for you and your family when used in hospitals all over the world.”
How do you handle this?
- As a Quality Assurance Engineer, you are constantly busy with…. Getting the quality of data and documents to the highest needed level. Technical documents and information are your second nature and part of your Technomed life.
- You collect and analyse data to make decent and well-founded technical document that can be share with customer, regulatory authorities and notified body. You are involved in audit from any of these organisations.
- You are able to handle complexity, handling different concurrent tasks and prioritise your own work, and have the flexibility to adapt quickly to new priorities
Who are you?
- You have at least three years expertise in design control and preferably have a, engineering or scientific Bachelor’s degree or experience in life sciences, (bio)medical, chemistry, pharmacy or other related expertise.
- You have demonstrable working experience with Design control according ISO 13485 (2016), risk management according ISO 14971 and Usability according IEC 62366.
- You know how to write specification requirements, set control limits and complete trend analyses, with applicable statistical methods.
- English? YES! Dutch? Dat is handig! You make an impression with your English either orally and in writing.
- Your smooth communication style gives you the advantage that you can level with all kinds of individuals and you are a team player in heart and soul.
- You learn quickly, are eager to develop and take proactivity of paramount importance.
- You enjoy helping the organisation to level up. Offering added value: that is what you live for!
Why would you work for us?
You will be part of the growing and ambitious environment of the Welcony group. A dynamic organization in full expansion, internationally oriented and with an absolute drive to maintain mentality and atmosphere of a small organization. We value a hands-on approach and allow you to excel, develop, create and implement your own expert knowledge that can be converted to the best results. We support talents to further develop their competences. We are a down-to-earth, results driven organization with short lines of communication and quick decision making. We have an ambition and passion to become a strong leader in the medical world. We want to realize this with the best people and breakthrough innovations.
Interested?
Please send your CV and motivation letter by submitting your application by using our Online Application Form For more information about the vacancy, please contact Monique Berwaer, Manager QA&RA, mberwaer@technomed.nl for information about our procedure contact Jefte Erens, Global HR Director, jerens@technomed.nl
Acquisition to this vacancy is not appreciated.
