Associate Director, Quality Medical Devices

4 weeks ago


California, United States BioPhase Full time

Remote or Hybrid (if local to San Diego)

The qualified candidate will have direct oversight of the three pillars of our quality assurance program: quality systems and risk management, product line quality, and stewardship and compliance. The successful candidate will work with quality leadership to develop and execute the short and long-term strategy of the quality assurance function. This role plays a key part in representing to external customers, including global regulatory agencies.

Responsible for coordinating and leading the quality assurance function, with direct oversight of quality systems and risk management, product line quality and stewardship and compliance.
Contribute to and deliver on the quality function’s strategic plan and annual OKRs and communicate across the business.
Monitor business and quality KPIs to identify trends and recommend opportunities for improvement.
Foster a culture of quality, risk management, and continuous improvement across the organization.
Lead product quality efforts by creating and incorporating quality procedures, standards, and specifications to enable timely product delivery to customers.
Create and manage quality reports and dashboards to provide real-time visibility into product quality and supply to enable accurate planning and forecasting.
Responsible for providing reports with the appropriate level of detail and frequency to the Quality Leadership and executives using data analysis and reporting tools to influence organizational decisions through communicating timely and accurate information.
Support consistency in quality methodologies, processes, and procedures across commercial production activities.
Evolve and sustain the quality culture where quality is clearly understood and recognized as a driver to improve both the customer experience and business performance.

Master’s degree or bachelor’s degree in agriculture, Agronomy, Supply Chain or Biology (Agriculture is preferred) with 3-5 years or 10+ years’ experience, respectively.
~ Strong understanding of quality management systems (ISO9001) and regulatory principles with broad experience in implementing and managing a quality program across an organization, with line management experience.
~ Demonstrated ability to lead and manage teams of direct and indirect reports to achieve technical and professional growth success.
~ Ability to develop and implement quality processes and programs by working with stakeholders and functional leaders.
~ Knowledge of NetSuite, Power BI, and ZenQMS is a definite advantage.
~10-20% travel anticipated.


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