Job Title: Director of Quality Assurance

Location: Santa Rosa, CA (On-site, Full-Time)
Schedule: Monday–Friday, with availability for occasional Saturdays as needed
Competative Salary with potential of Bonus

Overview:
We are seeking an experienced and strategic Director of Quality Assurance to lead and manage all aspects of quality systems and regulatory compliance for a well-established company in the medical products industry. This leadership role is responsible for overseeing quality initiatives, regulatory submissions, risk management, and ensuring compliance with applicable global regulations.

Key Responsibilities:

• Oversee and maintain the Quality Management System (QMS), driving continuous improvement efforts.

• Ensure compliance with FDA, ISO 13485, EU MDR, and other applicable regulatory standards.

• Lead document control, training, and quality system processes.

• Participate in global regulatory submissions and manage review of product changes and labeling.

• Direct internal and external audits, ensuring readiness and successful outcomes.

• Provide regulatory guidance across cross-functional teams and lead QA strategic initiatives.

• Mentor and manage QA team members to foster growth and performance.

• Monitor industry trends and regulatory changes to maintain compliance and competitive advantage.

• Collaborate with leadership on departmental goals and operational planning.

Qualifications:

• Bachelor’s degree in a scientific discipline required (Master’s preferred).

• Minimum of 10 years in quality assurance leadership within the medical or pharmaceutical industry.

• Strong knowledge of FDA regulations, ISO 13485, EU MDR, and related global requirements.

• Proven success managing regulatory submissions (FDA 510(k), international dossiers, etc.).

• Skilled in risk management, design control, and validation processes.

• Demonstrated leadership, project management, and strategic planning experience.

Skills & Competencies:

• Strong written and verbal communication skills.

• Detail-oriented with excellent problem-solving and decision-making abilities.

• High proficiency in technical documentation, statistical analysis, and MS Office applications.

• Ability to lead and influence cross-functional teams effectively.

• Comfortable working under tight deadlines and adapting to business needs.

Additional Details:

• This is a full-time, on-site position located at our headquarters in Santa Rosa, CA.

  • Availability to work one Saturday per month and other hours as needed.
    
    
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