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Quality Assurance Engineer / Medical Device
Location: Drachten, Netherlands
About the Role:
As a Quality Assurance Engineer, you will play a critical role in ensuring the highest quality standards for our medical devices. You will be the ambassador and driving force behind our quality policy, working within a regulated quality management system. You will have a growing mindset and a strong focus on continuous improvement.
Key Responsibilities:
-
Quality Assurance & Compliance:
- Conduct thorough risk-based assessments of documentation and perform final releases of medical devices.
- Proactively identify, address, and follow up on nonconformities, collaborating with cross-functional teams to implement effective corrective and preventive actions.
- Initiate and support process and product changes through regulated Change Management processes, ensuring compliance with all relevant regulations and standards.
- Maintain a strong understanding of applicable regulatory requirements (e.g., ISO 13485, MDR) and ensure compliance throughout the product lifecycle.
-
Risk Management:
- Conduct thorough risk assessments and implement appropriate risk mitigation strategies.
- Participate in the development and maintenance of the company's Quality Management System.
-
Communication & Collaboration:
- Effectively communicate quality-related issues and findings to internal and external stakeholders.
- Collaborate closely with engineering, manufacturing, and other departments to ensure product quality and compliance.
- Provide technical expertise and guidance to other team members on quality-related matters.
-
Problem-Solving & Decision-Making:
- Demonstrate strong analytical and problem-solving skills to effectively address quality challenges.
- Make sound and timely decisions based on available data and risk assessments.
-
Continuous Improvement:
- Actively participate in continuous improvement initiatives to enhance product quality and efficiency.
- Identify and implement process improvements within the Quality Assurance function.
Qualifications & Experience:
- Education: MBO+/HBO degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related field. Equivalent experience may also be considered.
- Experience: Proven experience in a Quality Assurance role within the medical device industry is preferred.
- Technical Skills: Strong understanding of quality management systems, regulatory requirements (e.g., ISO 13485, MDR), risk management principles, and quality tools and techniques.
- Communication & Interpersonal Skills: Excellent written and verbal communication skills in both Dutch and English. Ability to effectively communicate technical information to both technical and non-technical audiences. Strong interpersonal and teamwork skills.
-
Other Skills:
- Detail-oriented with strong analytical and problem-solving skills.
- Ability to work independently and proactively while also effectively collaborating within a team environment.
- Ability to quickly adapt to changing priorities and navigate complex situations.
- A proactive and results-oriented approach with a strong commitment to quality.
Benefits:
- Competitive salary and benefits package.
- Opportunity to work on innovative and impactful medical devices.
- Collaborative and supportive work environment.
- Opportunities for professional growth and development.
Kwaliteitsingenieur / Medisch Hulpmiddel
Locatie: Drachten, Nederland
Over de rol:
Als Kwaliteitsingenieur speel je een cruciale rol bij het garanderen van de hoogste kwaliteitsnormen voor onze medische hulpmiddelen. Je bent de ambassadeur en drijvende kracht achter ons kwaliteitsbeleid en werkt volgens een gereguleerd kwaliteitsmanagementsysteem. Je hebt een groeiende mindset en een sterke focus op continue verbetering.
Belangrijkste verantwoordelijkheden:
-
Kwaliteitsborging & Compliance:
- Voer grondige risicogebaseerde beoordelingen van documentatie uit en voer definitieve releases van medische hulpmiddelen uit.
- Proactief identificeren, aanpakken en opvolgen van afwijkingen, samenwerken met cross-functionele teams om effectieve corrigerende en preventieve acties te implementeren.
- Initiëren en ondersteunen van proces- en productveranderingen via gereguleerde wijzigingsbeheerprocessen, waarbij wordt gegarandeerd dat aan alle relevante regelgeving en normen wordt voldaan.
- Handhaven van een goed begrip van toepasselijke regelgevingseisen (bijv. ISO 13485, MDR) en ervoor zorgen dat gedurende de hele productlevenscyclus aan de voorschriften wordt voldaan.
-
Risicomanagement:
- Voer grondige risicoanalyses uit en implementeer passende risicobeheersingsstrategieën.
- Neem deel aan de ontwikkeling en het onderhoud van het kwaliteitsmanagementsysteem van het bedrijf.
-
Communicatie & Samenwerking:
- Communiceer kwaliteitsgerelateerde problemen en bevindingen effectief met interne en externe stakeholders.
- Werk nauw samen met engineering, productie en andere afdelingen om productkwaliteit en compliance te garanderen.
- Verstrek technische expertise en begeleiding aan andere teamleden over kwaliteitsgerelateerde zaken.
-
Probleemoplossing & Besluitvorming:
- Demonstreer sterke analytische en probleemoplossende vaardigheden om kwaliteitsproblemen effectief aan te pakken.
- Neem weloverwogen en tijdige beslissingen op basis van beschikbare gegevens en risicobeoordelingen.
-
Continue verbetering:
- Actief deelnemen aan continue verbeteringsinitiatieven om de productkwaliteit en efficiëntie te verbeteren.
- Identificeer en implementeer procesverbeteringen binnen de Kwaliteitsborgingsfunctie.
Kwalificaties & Ervaring:
- Opleiding: MBO+/HBO-diploma in Werktuigbouwkunde, Industrieel Ingenieur, Biomedische Technologie of een aanverwant vakgebied. Equivalente ervaring kan ook worden overwogen.
- Ervaring: Ervaring in een Quality Assurance-rol binnen de medische hulpmiddelenindustrie is geprefereerd.
- Technische vaardigheden: Goede kennis van kwaliteitsmanagementsystemen, wettelijke vereisten (bijv. ISO 13485, MDR), risicomanagementprincipes en kwaliteitsinstrumenten en -technieken.
- Communicatie- & Interpersoonlijke vaardigheden: Uitstekende mondelinge en schriftelijke communicatievaardigheden in zowel Nederlands als Engels. Vermogen om technische informatie effectief te communiceren aan zowel technische als niet-technische doelgroepen. Sterke interpersoonlijke en teamvaardigheden.
-
Overige vaardigheden:
- Nauwgezet met sterke analytische en probleemoplossende vaardigheden.
- Zelfstandig en proactief kunnen werken en tegelijkertijd effectief kunnen samenwerken binnen een teamomgeving.
- Vermogen om zich snel aan te passen aan veranderende prioriteiten en complexe situaties te navigeren.
- Een proactieve en resultaatgerichte aanpak met een sterke betrokkenheid bij kwaliteit.
Voordelen:
- Competitief salaris- en arbeidsvoorwaardenpakket.
- Mogelijkheid om te werken aan innovatieve en impactvolle medische hulpmiddelen.
- Een samenwerkingsgerichte en ondersteunende werkomgeving.
- Kansen voor professionele groei en ontwikkeling.
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