Manager, Quality Assurance (39976)

Young Innovations•Santa Maria, CA

9d•$110,000 - $140,000

About The Position

Lead and continuously improve the Quality System to ensure Preat’s products are safe, effective, and compliant throughout their lifecycle. Play a key role in driving quality excellence, regulatory compliance, and operational performance across the business. You’ll like this role if: You enjoy owning and improving quality systems, not just maintaining them. You like working cross-functionally and being a key partner to operations, customer service, and leadership. You are energized by solving problems, driving continuous improvement, and making a visible impact. You want hands-on exposure across multiple areas of Quality, including audits, CAPA, compliance, and process improvement. Why You’ll Love Working Here: Medium-sized company; not too big, not too small; just enough to make an impact and get things done. Your work directly impacts product quality, regulatory compliance, and overall company success. Opportunity to take ownership of the Quality System and influence how processes evolve and improve. Competitive benefits package including medical, dental, vision, 401k, parental leave, paid holidays, PTO, disability coverage, EAP, and more. Who you’ll work with: This role partners cross-functionally with Operations, Customer Service, Quality & Regulatory Affairs, and leadership across the organization. You will work closely with the VP of Quality & Regulatory Affairs, Director of Operations, and Senior Customer Service Manager. What You’ll Do: Quality Systems & Compliance Lead and maintain the Quality Management System (QMS), ensuring compliance with internal standards and regulatory requirements (FDA, ISO, etc.). Develop and maintain quality plans, including risk assessments, hazard analyses, and control measures. Establish and validate quality processes, including product specifications, monitoring, and documentation. Audits, CAPA & Continuous Improvement Conduct internal audits and lead external audits (ISO, FDA, and other regulatory bodies). Investigate customer complaints and non-conformances; drive corrective and preventive actions (CAPA). Analyze quality data and trends to identify opportunities for improvement and implement solutions. Cross-Functional Leadership & Support Partner with Operations and other teams to improve processes, support product development, and enhance efficiency. Train and support employees on quality procedures, policies, and compliance expectations. Contribute to strategic initiatives and continuous improvement efforts across the business. Innovation & Growth As part of a smaller, innovative organization, contribute to new processes, evolving technologies, and continuous improvement initiatives.

Requirements

Bachelor’s degree in a science or technical field.
At least 3 years of Quality Assurance experience in a medical device or pharmaceutical environment.
Experience supporting or participating in regulatory audits and/or FDA inspections.
A proactive, hands-on approach with the ability to take ownership and drive results.
Working knowledge of quality systems, processes, and applicable medical device or pharmaceutical regulations.
Strong written and verbal communication skills, with the ability to clearly present information and findings, including to leadership.
Self-starter who can work independently while collaborating effectively across all levels of the organization.
Strong attention to detail with excellent documentation and record-keeping skills.
Highly organized with strong planning, coordination, and problem-solving abilities.
Demonstrated ability to maintain a strong quality focus while balancing multiple priorities.

Responsibilities

Lead and maintain the Quality Management System (QMS), ensuring compliance with internal standards and regulatory requirements (FDA, ISO, etc.).
Develop and maintain quality plans, including risk assessments, hazard analyses, and control measures.
Establish and validate quality processes, including product specifications, monitoring, and documentation.
Conduct internal audits and lead external audits (ISO, FDA, and other regulatory bodies).
Investigate customer complaints and non-conformances; drive corrective and preventive actions (CAPA).
Analyze quality data and trends to identify opportunities for improvement and implement solutions.
Partner with Operations and other teams to improve processes, support product development, and enhance efficiency.
Train and support employees on quality procedures, policies, and compliance expectations.
Contribute to strategic initiatives and continuous improvement efforts across the business.
As part of a smaller, innovative organization, contribute to new processes, evolving technologies, and continuous improvement initiatives.