QA Specialist

QA Specialist

Location: Utrecht

About the company: a leading organization in the medical device industry, dedicated to enhancing life sciences through innovative solutions. The company is committed to maintaining high standards of quality and regulatory compliance to ensure the safety and efficacy of their products.

Job Summary: the QA Specialist will be responsible for overseeing and managing regulatory compliance and quality management systems within the organization. The ideal candidate will have a strong understanding of ISO 13485 standards, IVDD directives, and experience with CE marking and FDA approvals. This role requires an individual who can work independently, is a quick learner, and has a keen interest in bioinformatics, biology, and software testing.

Key Responsibilities:

Regulatory Management:

• Act as PRRC (Person Responsible for Regulatory Compliance) according to Article 15 of IVD-R (Regulation 2017/746).
• Monitor applicable regulatory requirements of targeted markets.
• Define IVD regulatory pathways for targeted markets.
• Create and maintain a regulatory roadmap.
• Review technical documents for completeness and accuracy.
• Apply for regulatory submission of IVD products.
• Register medical devices with local authorities or notify them as required.
• Report incidents to authorities and notified bodies promptly.

Quality System Management:

• Monitor applicable standards and guidance documents.
• Introduce new quality processes, procedures, and standards across the company.
• Lead quality initiatives and projects company-wide.
• Ensure that processes under the Quality Management System (QMS) are fully documented.
• Establish, implement, and maintain QMS documentation for the Quality Management department.
• Define requirements for document control company-wide and maintain the Master Document List for procedures and quality documents.
• Ensure company-wide awareness of applicable regulatory and QMS requirements.
• Create and manage a yearly audit plan, including internal, supplier, and 3rd party (Notified Body) audits.
• Prepare for and manage 3rd party audits company-wide.
• Perform internal and supplier audits according to the yearly audit plan.
• Report to top management on the effectiveness of the QMS and identify any areas for improvement.
• Ensure quality control of supplier management by:
  • Establishing and maintaining QMS and regulatory requirements in supplier agreements.
  • Defining quality criteria in supplier evaluations and performing evaluations with the COO.
  • Defining verification processes for supplied products.
  • Establishing and maintaining supplier-related complaint handling processes.
• Monitor the execution of complaint categorization daily.
• Establish and maintain a CAPA procedure to drive problem-solving and continual improvement processes.
• Raise CAPAs and inform the Compliance Committee in case of potential adverse events and regulatory issues.
• Establish risk management processes and participate in risk assessments.
• Act as the Management Representative for the company.

Qualifications:

• Strong understanding of ISO 13485 standards and IVDD directives.
• Proven experience with ISO 13485, CE marking, and FDA approvals.
• Ability to work independently and manage multiple tasks effectively.
• Experience in life sciences is an advantage.
• Knowledge of biology and genetics.
• Quick learner with an interest in bioinformatics, biology, and software testing.
• Fluent in English.

What We Offer:

• Competitive salary and benefits package.
• Opportunity to work in a dynamic and innovative environment.
• Career growth and development opportunities.
• Collaborative and supportive team culture.

If interested, please feel free to reach out via: a.ahmadi(@)realstaffing.com / +31 6 21389726