Head Of Quality Assurance

Head of Quality Assurance - Medical Device

Location: Remote within the US

Position Overview:

As the Head of Quality Assurance, you will be responsible for developing and implementing a comprehensive quality management system to ensure the highest level of product quality and regulatory compliance across all aspects of our organization. This position is crucial in maintaining the company's commitment to delivering safe and effective medical devices to their customers.

Responsibilities:

1. Develop and execute the overall quality strategy: Define and implement a strategic roadmap for quality assurance, including goals, objectives, and key performance indicators (KPIs), to enhance product quality and regulatory compliance.
2. Establish and maintain a robust quality management system (QMS): Design, implement, and maintain an effective QMS that complies with relevant regulations and industry standards, such as ISO 13485 and FDA requirements.
3. Ensure compliance with regulatory requirements: Stay up-to-date with relevant regulations and standards in the medical device industry, and ensure the company's compliance with all applicable regulations, including FDA, EU MDR, and other global regulatory requirements.
4. Drive continuous improvement: Lead efforts to continuously improve quality systems, processes, and procedures to enhance product quality, reduce defects, and increase customer satisfaction.
5. Manage and lead the quality assurance team: Provide leadership, guidance, and mentorship to the quality assurance team, including hiring, training, performance management, and professional development.
6. Conduct internal and external audits: Plan and conduct internal audits to assess compliance with quality standards and regulatory requirements. Coordinate external audits by regulatory authorities and notified bodies.
7. Support product development and lifecycle management: Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality requirements are integrated into the product development process and maintained throughout the product lifecycle.
8. Manage non-conformance and corrective actions: Lead investigations into product non-conformances and customer complaints, implement appropriate corrective and preventive actions (CAPAs), and track their effectiveness.
9. Implement risk management practices: Drive the implementation and integration of risk management practices, such as FMEA (Failure Mode and Effects Analysis), to identify and mitigate potential risks associated with product quality.
10. Foster a culture of quality and compliance: Promote a culture of quality throughout the organization by providing training, guidance, and support to all employees, and by fostering a proactive and accountable approach to quality and regulatory compliance.

Qualifications and Skills:

• Proven track record of developing and implementing quality management systems in compliance with regulatory requirements.
• Bachelor's degree in engineering, life sciences, or a related field; advanced degree is preferred.
• Experience in leading and managing quality assurance teams, including hiring, training, and performance management.
• Proficient in conducting internal and external audits, and interacting with regulatory authorities and notified bodies during inspections.
• Strong knowledge of class III Medical Devices
• Excellent problem-solving and analytical skills, with the ability to make data-driven decisions.
• In-depth understanding of risk management practices and their application in the medical device industry.
• In-depth understanding of relevant quality standards, regulations, and guidelines, such as ISO 13485, FDA QSR, EU MDR, and other global regulatory requirements.
• Strong communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and senior management.
• Minimum of 10 years of experience in quality assurance within the medical device industry, with at least 5 years in a leadership or managerial role.
• Detail-oriented mindset with a commitment to delivering high-quality products and achieving regulatory compliance.

If you have a passion for quality, compliance, and improving patient outcomes, we invite you to apply today.