Job Description

We are seeking a Quality Manager to lead site-level quality operations at our Santa Rosa facility. In this role, you’ll oversee the implementation of quality systems and controls, ensure compliance with regulatory standards, and drive continuous improvement across the production lifecycle. You'll work cross-functionally to maintain the highest standards of quality and customer satisfaction.

Key Responsibilities

• Lead, coach, and develop a quality assurance team to meet organizational and regulatory goals
• Oversee hiring, training, and performance management within the quality department
• Develop and maintain quality control processes, including audits, inspections, and corrective actions
• Monitor key quality metrics and analyze trends to inform strategy and improve performance
• Partner with production, engineering, and leadership teams to resolve quality issues and align on customer expectations
• Ensure compliance with ISO 13485, FDA regulations, and internal GMP standards
• Support new product introductions by ensuring quality plans are clear, realistic, and effective
• Communicate key quality developments and risks to leadership in a timely, actionable way
• Lead investigations and root cause analysis to reduce scrap and improve process capability
• Conduct regular system and product audits
• Maintain up-to-date knowledge of industry quality standards and codes

Leadership Competencies

• Builds Effective Teams – Fosters collaboration and unites diverse perspectives to achieve results
• Drives Results – Consistently delivers high-quality outcomes, even in challenging circumstances
• Ensures Accountability – Sets clear expectations and follows through
• Instills Trust – Operates with transparency, integrity, and credibility
• Manages Complexity – Breaks down complex issues and leads data-driven problem solving
• Plans and Aligns – Prioritizes and executes tasks to support strategic goals

Qualifications

Required:

• Bachelor’s degree
• Minimum 5 years of quality-related experience, including 2+ years in a leadership role
• Strong knowledge of ISO 13485 and manufacturing environments
• Proficiency in statistical analysis and quality metrics
• Excellent communication, training, and leadership skills

Preferred:

• Experience in FDA-regulated environments (FDA 820, 210/211)
• ASQ certifications (CQE, CQM, CQA)
• Background in injection molding
• Six Sigma (Green or Black Belt), Lean, or Kaizen training

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