Director of Quality
1 week ago
Job Title:
Director of Quality
Location:
Massachusetts, USA
Company:
Leading Medical Device Manufacturer (implantable)
Position Overview:
Our client are seeking an experienced and highly motivated Director of Quality to join their dynamic team. The Director of Quality will be responsible for leading and overseeing all aspects of quality assurance and quality control within the company. This role is crucial in ensuring their products meet the highest standards of safety, efficacy, and compliance with regulatory requirements. The ideal candidate will have a strong background in the medical device industry, a deep understanding of quality systems, and a proven track record of leadership and team development.
Key Responsibilities:
Leadership and Strategy:
Develop and implement the overall quality strategy in alignment with the company’s objectives and regulatory requirements.
Lead and mentor the quality assurance and quality control teams, fostering a culture of continuous improvement and accountability.
Collaborate with cross-functional teams including R&D, manufacturing, and regulatory affairs to ensure quality is integrated into all processes.
Quality Management System (QMS):
Oversee the maintenance and continuous improvement of the company’s QMS in compliance with ISO 13485, FDA regulations (21 CFR Part 820), and other relevant standards.
Ensure all quality processes, procedures, and documentation are up-to-date, effective, and compliant.
Lead internal and external audits, ensuring timely and effective resolution of findings.
Regulatory Compliance:
Ensure compliance with all relevant regulatory requirements and standards for medical devices.
Manage and oversee regulatory inspections and audits, including FDA, notified body, and other regulatory bodies.
Stay current with changes in regulations and standards, and ensure the company’s quality system adapts accordingly.
Product Quality:
Oversee product quality from development through manufacturing and post-market surveillance.
Implement and monitor key quality metrics, ensuring products meet predefined specifications and quality standards.
Lead investigations into product non-conformances, complaints, and CAPAs, driving root cause analysis and effective corrective actions.
Supplier Quality Management:
Develop and maintain a robust supplier quality management program.
Conduct supplier audits and assessments to ensure compliance with company and regulatory requirements.
Collaborate with suppliers to drive quality improvements and resolve quality issues.
Training and Development:
Ensure all employees are trained on quality policies, procedures, and regulatory requirements.
Develop and implement quality training programs to enhance the skills and knowledge of the quality team and other relevant staff.
Qualifications:
Bachelor’s degree in Engineering, Life Sciences, or a related field. Advanced degree preferred.
Minimum of 10 years of experience in quality assurance/control within the medical device industry.
Proven leadership experience with a track record of building and managing high-performing teams.
In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and other relevant medical device regulations and standards.
Experience with regulatory inspections and audits, including FDA and notified bodies.
Strong problem-solving skills, with experience in root cause analysis and CAPA management.
Excellent communication skills, with the ability to effectively interact with all levels of the organization and external partners.
Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar certifications are a plus.
Benefits:
Competitive salary and performance-based bonuses
Comprehensive health, dental, and vision insurance
401(k) with company match
Paid time off and holidays
Professional development opportunities
A collaborative and innovative work environment
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