Associate Director of Device Quality – Medical Device
San Diego, CA 92121
Our client is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce an efficacious, robust and tolerable immune response. Are you ready to contribute the continued development of this life saving technology?
The Associate Director, Device Quality has a thorough understanding of the design control process, FDA and ISO standards, and product life cycle. This role interacts closely with Engineering, Manufacturing, and Regulatory Affairs to provide Quality support and leadership throughout the medical device cGMP environment. The Associate Director of Device Quality is responsible for leading, coaching and mentoring a team of quality professionals in medical device quality assurance, quality control, quality engineering and document control. This role is responsible for maintaining Quality function responsibilities in support of both commercial level production and in development of new products.
Provide team leadership for Medical Device Quality group, including staff management and mentorship, resource scheduling, project support and QMS compliance.
- Act as subject matter expert and apply risk based and FMEA approaches to support risk management efforts.
- Maintain and support medical device Quality System compliance through leadership and active participation in all elements of Quality Assurance.
- Review and approve documentation: requirements, plans, specifications & drawings, procedures (test, manufacturing and QC), reports, design reviews and validation.
- Provide Quality leadership in support for production, QC and all investigations.
- Interact closely with technicians, Manufacturing, Marketing, Materials, and Research to support existing and new products.
- Participate in remediation of product documentation for changes in product compliance for new or updated regulations.
- Support QMS compliance NCMR and CAPA root cause investigation and develop corrective and preventive action as necessary.
- Provide Quality support in management of suppliers, contract manufacturers and service organizations
- Participate in Quality Agreement review and approval and perform internal and external audits as required.
- Provide support for Quality System audits, including audits by partners, agencies and notified body.
- Identify and drive improvements to Quality Management system ensuring continued improvement and compliance to corporate policies and industry regulations.
- Bachelor’s degree in related field
- Minimum 8 years of related Quality management experience; medical device environment strongly preferred.
- Minimum 3 years of management experience.
- Solid understanding of medical device regulations and regulatory requirements, such as FDA, cGMP, ISO, CE, MDR.
- Experience with Quality oversight of products from concept through validation and commercial manufacturing.
- Engineering experience strongly preferred.
- Experience with quality tools, such as: SPC, Advanced Quality Planning, Control Plans, FMEA, Six Sigma, etc.
- The ability to perform typical office activities.
- Experience working with contract manufacturers and vendor audits.
- Excellent teamwork and written and verbal communication skills.
Competitive salary and benefits package