QA Manager

Job Summary: As a QA Manager at our office, you will be responsible for carrying tasks in preparation for a notified body audit for ISO 13485 and MDR requirements. You will assist in implementing the new requirements of MDR, write documents, train employees, ensure that the quality management system complies with other applicable regulatory requirements.

Responsibilities:

• Ensure proper installation and testing processes of systems.
• Verify the integrity of the Device History Record (DHR) by ensuring the completeness and accuracy of the DHR, including all relevant documentation and records.
• Continuously improve the work instructions, forms and tests.
• Manage DCOs/ECOs corrective actions and follow-up until closure.
• Ensure compliance with relevant regulations (e.g. QSR, MDR), standards (e.g., ISO 13485, ISO 14971), and customer requirements.
• Identify potential quality issues and develop mitigation plans.
• Ensure implementation of design control requirements in R&D including employees training and qualifications.
• Manage QA activities for design and development of a multi-disciplinary device.
  
  

• Education, Technical Knowledge and Experience:
• Minimum of 2-4 years of experience in quality assurance in medical devices.
• Experience with transfer from MDD to MDR.
• Familiarity with quality management system standards (e.g., ISO 13485).
• Familiarity with risk management principles (e.g., ISO 14971).
• Strong understanding of quality assurance and quality control principles and methodologies.
• Skills and Attributes:
• Excellent attention to detail and ability to identify potential quality issues.
• Effective communication and interpersonal skills to collaborate with cross-functional teams.
• Strong problem-solving skills with ability to meet requirements.
• Ability to prioritize tasks and work in a fast-paced, deadline-driven environment.