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Director of Quality
4 months ago
I'm working with a leading Class III medical device company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to excellence and quality is at the forefront of everything we do. We are seeking a highly skilled and experienced Director of Quality Assurance to join our team and lead our quality efforts.
Position Overview:
As the Director of Quality Assurance, you will be responsible for ensuring that our medical devices meet the highest standards of quality, safety, and regulatory compliance. You will lead a team of quality professionals and work closely with cross-functional teams to develop, implement, and maintain quality systems and processes throughout the product lifecycle.
Key Responsibilities:
Leadership and Strategy:
Provide strategic leadership and direction for the quality assurance function as a Site Head of Quality.
Develop and implement a comprehensive quality strategy aligned with business objectives.
Drive a culture of quality and continuous improvement throughout the organization.
Quality Management Systems (QMS):
Oversee the development, implementation, and maintenance of the QMS in accordance with FDA regulations, ISO standards, and other applicable regulatory requirements.
Ensure that QMS processes are effective, efficient, and compliant with regulatory standards.
Conduct regular audits and assessments to monitor the effectiveness of the QMS and identify areas for improvement.
Regulatory Compliance:
Stay abreast of changes in regulations and standards relevant to medical device manufacturing.
Ensure compliance with FDA regulations, ISO standards, MDR, and other applicable regulatory requirements.
Interface with regulatory agencies during inspections and audits.
Quality Assurance Operations:
Establish and maintain quality metrics and key performance indicators (KPIs) to monitor product quality and process performance.
Lead investigations into quality issues, non-conformances, and complaints, and implement corrective and preventive actions (CAPAs) as necessary.
Manage supplier quality programs to ensure the quality and reliability of purchased components and materials.
Cross-functional Collaboration:
Collaborate with R&D, Manufacturing, Engineering, and other departments to ensure that quality requirements are integrated into product development and manufacturing processes.
Provide quality oversight for new product development projects, including design controls, risk management, and validation activities.
Qualifications:
Bachelor's degree in Engineering, Life Sciences, or related field; advanced degree preferred.
Minimum of 8-10 years of experience in quality assurance within the medical device industry, with at least 5 years in a leadership role.
In-depth knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant quality standards.
Proven track record of successful interactions with regulatory agencies (FDA, Notified Bodies, etc.).
Strong leadership, communication, and interpersonal skills.
Experience with risk management, design controls, and validation processes.
Ability to lead and motivate cross-functional teams in a dynamic and fast-paced environment
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