Role: Director of Quality Affairs / Assurance

We are an innovative company within the medical device industry, dedicated to developing cutting-edge technologies that address significant clinical challenges. Our unique products are designed to improve patient outcomes, particularly in specialized areas of surgical care. Our flagship product has already begun to make a meaningful impact in its field, with additional products in various stages of regulatory review and development. We are seeking a highly skilled Director of Quality Affairs to join our growing team.

Position Summary

The Director of Quality Affairs is a key member of the leadership team, responsible for overseeing the company's commitment to quality excellence on a daily basis. This role involves the development, implementation, and maintenance of quality assurance systems and processes. The successful candidate will ensure that our products comply with all relevant quality and regulatory requirements, thereby ensuring optimal performance and patient safety. The Director will lead all quality-related functions, including quality control, regulatory compliance, and continuous improvement initiatives.

Responsibilities

Quality Management:

• Maintain and enhance comprehensive quality management systems (QMS) to meet regulatory and industry standards.
• Oversee quality control processes to guarantee the production of high-quality products.
• Monitor and report key quality metrics and trends to senior management.

Regulatory Compliance:

• Ensure compliance with all pertinent regulatory requirements, including those of the FDA, ISO, and other international bodies.
• Lead and manage regulatory inspections and audits.
• Prepare and submit necessary regulatory filings and documentation.

Continuous Improvement:

• Lead initiatives aimed at continuously improving product quality and operational efficiency.
• Identify process improvement opportunities and implement effective solutions.
• Promote a culture of quality and continuous improvement across the organization.

Leadership and Collaboration:

• Lead and manage the quality affairs team, providing direction, training, and development.
• Work closely with cross-functional teams, including R&D, manufacturing, and commercial teams, to ensure quality throughout the product lifecycle.
• Serve as the primary contact for quality-related matters with external partners and regulatory bodies.

Risk Management:

• Develop and implement strategies to identify, assess, and manage risks related to quality assurance.
• Conduct regular risk assessments and corrective and preventive actions (CAPA) as necessary.

Knowledge, Skills, and Abilities:

• In-depth knowledge of quality management systems, regulatory requirements, and industry standards in the medical device sector.
• Proven track record of leading and managing quality assurance and regulatory affairs functions.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to thrive in a fast-paced, dynamic environment.
• Proficiency with quality management software and tools.
• Strong leadership and team management capabilities.

Education/Experience:

• Bachelor’s degree in a relevant field; an advanced degree is preferred.
• At least 5 years of experience in quality assurance within the medical device industry.
• Experience with FDA regulations, ISO standards, and other relevant regulatory requirements.

Working Conditions:

• Frequent standing, walking, sitting, and desk-based computer tasks.
• Occasionally lifting, carrying, pushing, and pulling objects over 40 pounds.
• The role is performed in office and laboratory environments, with occasional exposure to noise, dust, chemicals, operating machinery, and temperature variations.

Location: This position is based at our headquarters in Los Gatos, CA.