Amaris Consulting - Eindhoven
Job description We are seeking a highly skilled and motivated Quality Assurance Specialist to join our dynamic team. The successful candidate will play a crucial role in ensuring compliance with quality management systems - Volledige vacature bekijken
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Quality Assurance Specialist StockX
We are seeking a highly skilled and motivated Quality Assurance Specialist to join our dynamic team. The successful candidate will play a crucial role in ensuring compliance with quality management systems and regulations in the medical device industry. This position offers an exciting opportunity for individuals with a deep understanding of regulatory requirements and a passion for maintaining the highest standards of quality.
Key Responsibilities:
- Conduct Corrections and Removals (C&R) activities in accordance with company procedures and regulatory requirements.
- Lead Corrective and Preventive Action (CAPA) initiatives to address quality issues and drive continuous improvement.
- Collaborate with cross-functional teams to implement process improvements and ensure adherence to quality standards.
- Perform quality engineering tasks related to product development, manufacturing, and post-market surveillance.
- Maintain and update quality management systems to comply with relevant regulations (e.g., 21 CFR Parts 803, 806, and 820, EU MDR, ISO 13485, ISO 14971, Canadian Medical Devices Regulation, and Japanese MHLW Ordinance 169).
- Conduct internal audits and assist in external audits by regulatory agencies and notified bodies.
Requirements:
- Bachelor's or Master's degree in Healthcare, Engineering, Science, or a related field.
- Minimum of 3 years of experience in Quality Assurance roles within the medical device industry.
- Strong understanding of quality management systems and regulatory requirements.
- Experience with Corrections and Removals (C&R) processes and Corrective and Preventive Action (CAPA) initiatives.
- Certifications such as Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) are a plus.
- Fuent in English (Dutch is a plus)
What we offer:
Join our dynamic team of talented people and discover a world full of growth and opportunity. Here's what we offer:- Rapid growth through a personalized career path and salary evaluation. 70% of our senior leaders started in entry-level roles.
- A competitive salary and benefits package
- Hone your skills through our catalogue of our Technology Academy, the Udemy platform, language lessons, webinars and workshops.
- Take control of your training with an annual personal budget and company-paid certifications.
- Enjoy flexible policies, remote work options, and great social benefits like transportation, help with relocation for internationals and collective health insurance.
- Take advantage of our WeCare program, which provides support to employees in critical situations.
- Unleash your full potential, both professionally and personally.
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