Position: Director of Quality Assurance
Department: Quality Assurance/Regulatory Affairs
Location: Santa Clara, CA
Reports to: VP of Operations
Purpose of Job
Plan and direct establishment of quality assurance standards. Responsible for the application and maintenance of quality standards as they apply to products and services of the company both nationally and internationally. Ensure compliance with all U.S. and international regulatory requirements pertaining to company products.
Major Duties and Responsibilities
- Develop, implement and maintain Company Quality System in accordance with QSR, and ISO13485.
- Knowledgeable in IEC 60601-1/-2, and UL listing.
- Work with engineering staff (both R&D and Mfg) in process development, improvement and quality control.
- Act as the primary contact (Management Representative) with regulatory agencies and notified bodies.
- Ensure overall company compliance to corporate quality Systems.
- Develop and implement methods and procedures for inspection, testing and evaluation of components, subsystems, and finished products.
- Knowledgeable in standard statistical techniques, both in application and analysis.
- Hire, train, and manage Quality Assurance management and staff.
- Maintain current knowledge of federal and state regulations regarding QSR, ISO, MDD, and quality assurance issues.
- Oversee Supplier audits and activities.
- Make presentations to the Design Review group and Executive Staff regarding project status.
- Manage the Document Control process.
- Manage complaint process, identify trends, and issues.
- Review and approve relevant documents, including SOP’s.
- Prepare and implement departmental budgets, performance management systems and staff development.
- Strong written, oral, and organizational skills required.
Education / Experience Requirements
BS in life sciences, engineering, or equivalent preferred, MS preferred. Minimum seven years related experience in the medical device industry, in addition to a minimum three years of supervisory experience. Highly developed communications and leadership skills. ASQC membership.