Associate Director, Quality
$160,000–$220,000 year
On-siteHayward, California, United States
Job Summary
Serve as the Management Representative for Quality, leading the Quality organization within a mid-to-large manufacturing facility and developing the plant's quality system. Oversee batch review and product release activities while fulfilling Person Responsible for Regulatory Compliance (PRRC) duties, ensuring device conformity verification and Post-Market Surveillance obligations. Direct large-scale programs to support division-wide objectives, manage regulatory inspections, and conduct periodic Quality Management System reviews with executive leadership. Drive continuous improvement initiatives, develop quality systems including CAPA and Design Controls, and assess acquisition targets for senior leadership. Lead coaching, training, and succession planning for the Quality team while collaborating across global functions and representing the organization to customers and regulatory agencies.
Required Qualifications
- In-depth knowledge of the regulatory environment governing the manufacture of medical devices and therapeutics
- Proven leadership experience managing large teams in a complex, regulated environment
- Demonstrated ability to lead within a matrix organization and collaborate effectively across global, cross-functional teams
- Strong analytical, problem-solving, and decision-making skills
- Excellent verbal and written communication skills
- Proven success working with multifunctional and global teams
- Strong interpersonal, influencing, and negotiation skills
- Extensive knowledge of applicable quality systems, regulatory standards, and industry regulations
- Experience in risk management, validation, analytics, and microbiology within a GMP-regulated environment
- Quality expertise supporting technology transfer initiatives
- Ability and willingness to work within ISO 7 and ISO 8 cleanroom manufacturing environments, including required gowning procedures
- Bachelor's degree in Science, Engineering, or a related technical discipline
- Minimum of 10 years of experience in Quality, Manufacturing, or a related field within the medical products industry
- Minimum of 7 years of management experience
- Applicants must be authorized to work for any employer in the U.S.
Desired Qualifications
- Advanced degree
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