Quality Assurance Manager

2 weken geleden


Varsseveld, Gelderland, Nederland Ecolab Voltijd
Job Description

We are seeking a highly skilled Quality Assurance Manager to join our team at Ecolab. As a key member of our Dutch operations, you will be responsible for ensuring the highest standards of quality and regulatory compliance in our medical devices business.

Key Responsibilities
  • Quality Management System: Develop and maintain a robust Quality Management System (QMS) that meets the requirements of ISO 13485 and EU MDR 2017/745.
  • Regulatory Compliance: Ensure compliance with all relevant regulatory requirements, including FDA 21 CFR Part 820, and maintain effective relationships with regulatory authorities.
  • Quality Assurance: Lead the quality assurance function, including the implementation of quality policies, procedures, and processes.
  • Training and Development: Provide training and development opportunities to ensure that all employees understand their roles and responsibilities in maintaining quality and regulatory compliance.
  • Continuous Improvement: Identify areas for improvement and implement changes to ensure that our QMS remains effective and efficient.
Requirements
  • Education: Bachelor's degree in a relevant field, such as quality assurance, engineering, or a related field.
  • Experience: Minimum 5 years of experience in quality assurance, regulatory compliance, or a related field.
  • Skills: Strong knowledge of ISO 13485, EU MDR 2017/745, and FDA 21 CFR Part 820; excellent communication and leadership skills; ability to work effectively in a team environment.
What We Offer
  • Competitive Salary: We offer a competitive salary and benefits package.
  • Opportunities for Growth: We offer opportunities for growth and development within the company.
  • Collaborative Environment: We have a collaborative and supportive work environment.

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