Director of Quality Assurance

Zenflow•South San Francisco, CA

43d•$190,000 - $225,000•Onsite

About The Position

Zenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring® technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props open the urethra, restoring its normal function while preserving the natural anatomy. The Zenflow Spring System is an investigational device and is not approved for commercial sale. POSITION OVERVIEW: The Director of Quality Assurance provides strategic direction, management, and alignment of quality functions to ensure overall compliance with applicable national and international regulations, standards and best practice including FDA QSR, ISO 13485, and EU MDD.

Requirements

Requires BS in a scientific or engineering discipline.
Minimum of 10 years of Quality Assurance experience in the medical device industry.
Minimum of 5 years of supervisory experience.
Requires written and verbal communication and interpersonal skills.
Ability to communicate and interact with individuals at all levels of responsibility.

Responsibilities

Serves as Management Representative
Hosts FDA and regulatory agencies’ quality system audits
Sets up Quality System policies and procedures to ensure compliance with FDA QSR, ISO 13485, and EU MDD requirements
Routinely evaluates the existing quality system to identify opportunities to streamline processes, and to ensure compliance with FDA QSR, ISO 13845, and MDD
Writes quality objectives
Manages quality resources, including personnel, equipment and budget in alignment with departmental and corporate goals
Performs Management Reviews and advise management of any product or process related issues and makes recommendations for improvements.
Plans and manages internal audit activities and coordinates audit corrective actions
Manages the quality group to ensure effective development and implementation of the Quality System Processes
Performs other duties as assigned