Quality Assurance Manager

About the Role

We are seeking an experienced and highly motivated Quality Assurance Manager to lead and oversee all aspects of our Quality Management System (QMS). This critical role ensures the development, manufacturing, and clinical use of safe and effective cardiovascular medical devices. The successful candidate will have a proven track record of success in the medical device industry and a deep understanding of relevant regulations and standards.

Key Responsibilities

• Quality Management System (QMS):
  • Develop, implement, and maintain a robust QMS compliant with FDA 21 CFR Part 820, ISO 13485, MDR, and other applicable international standards.
  • Oversee QMS documentation, including the development and revision of Standard Operating Procedures (SOPs), work instructions, and validation protocols.
  • Lead internal and external audits to assess QMS effectiveness and drive continuous improvement initiatives.
• Product Lifecycle Management:
  • Collaborate with cross-functional teams to ensure adherence to quality standards throughout the entire product lifecycle.
  • Provide guidance and support on design control, validation, and verification activities.
• Manufacturing Support:
  • Ensure compliance of in-house and contract manufacturing operations with all applicable quality standards and regulations.
  • Oversee quality control activities, including receiving inspections and final product release.
• Supplier Quality Management:
  • Establish and maintain a robust supplier quality program.
  • Collaborate with suppliers to ensure compliance with quality requirements and conduct periodic audits.
• Risk Management:
  • Serve as the subject matter expert for risk management practices, including FMEA and risk assessments.
  • Ensure the implementation of appropriate risk mitigation strategies and documentation.
• Compliance:
  • Maintain a current understanding of relevant regulations and standards.
  • Lead and support CAPA and non-conformance investigations.
  • Ensure timely and effective resolution of quality issues.

Qualifications

• Education: Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
• Experience: A minimum of 7 years of experience in quality assurance within the medical device industry, with at least 3 years in a leadership role. Experience with cardiovascular implants is highly preferred.
• Knowledge:
  • In-depth knowledge of FDA 21 CFR Part 820, ISO 13485, and other relevant medical device industry standards.
  • Strong understanding of risk management methodologies, CAPA processes, and product lifecycle management.
• Skills:
  • Excellent leadership, communication, and interpersonal skills.
  • Proven ability to collaborate effectively with cross-functional teams.
  • Strong analytical and problem-solving abilities.
  • Proficient in English (reading, writing, speaking).