Director of Quality Assurance

<b>About Zenflow</b><br><a href="http://www.zenflow.com/">Zenflow, Inc.</a>&#160;is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative S<span style="font-family:Arial, Helvetica, sans-serif;">pring&#174; technology was designed with the patient experience in mind and relies on a small spring-</span>like coil that gently props&#160;open the&#160;urethra, restoring its normal function while preserving the natural anatomy.&#160;The Zenflow Spring System is an investigational device and is not approved for commercial sale.<br><br><span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><b><span style="font-size:10pt;">POSITION OVERVIEW</span></b><span style="font-size:10pt;">:<br>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. </span></span><br><br><span style="font-size:12pt;"><b><span style="font-size:10pt;">MAJOR DUTIES AND RESPONSIBILITIES</span></b><span style="font-size:10pt;">:&#160; </span></span></span><ul style="margin-top:8px;margin-bottom:8px;"><li style="margin-top:8px;margin-bottom:8px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><span style="font-size:10pt;">Serves as Management Representative</span></span></span></li><li style="margin-top:8px;margin-bottom:8px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><span style="font-size:10pt;">Hosts FDA and regulatory agencies&#8217; quality system audits</span></span></span></li><li style="margin-top:8px;margin-bottom:8px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><span style="font-size:10pt;">Sets up Quality System policies and procedures to ensure compliance with FDA QSR, ISO 13485, and EU MDD requirements</span></span></span></li><li style="margin-top:8px;margin-bottom:8px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><span style="font-size:10pt;">Routinely evaluates the existing quality system to identify opportunities to streamline processes, and to ensure compliance with FDA QSR, ISO 13845, and MDD</span></span></span></li><li style="margin-top:8px;margin-bottom:8px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><span style="font-size:10pt;">Writes quality objectives</span></span></span></li><li style="margin-top:8px;margin-bottom:8px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><span style="font-size:10pt;">Manages quality resources, including personnel, equipment and budget in alignment with departmental and corporate goals</span></span></span></li><li style="margin-top:8px;margin-bottom:8px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><span style="font-size:10pt;">Performs Management Reviews and advise management of any product or process related issues and makes recommendations for improvements.</span></span></span></li><li style="margin-top:8px;margin-bottom:8px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><span style="font-size:10pt;">Plans and manages internal audit activities and coordinates audit corrective actions</span></span></span></li><li style="margin-top:8px;margin-bottom:8px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><span style="font-size:10pt;">Manages the quality group to ensure effective development and implementation of the Quality System Processes</span></span></span></li><li style="margin-top:8px;margin-bottom:8px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><span style="font-size:10pt;">Performs other duties as assigned</span></span></span></li></ul><br><span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><b><span style="font-size:10pt;">EDUCATION REQUIREMENTS</span></b><span style="font-size:10pt;">:&#160; Requires BS in a scientific or engineering discipline.&#160; </span></span><br><br><span style="font-size:12pt;"><b><span style="font-size:10pt;">EXPERIENCE REQUIREMENTS:&#160; </span></b><span style="font-size:10pt;">Minimum of 10 years of Quality Assurance experience in the medical device industry.&#160; Minimum of 5 years of supervisory experience.</span></span><br><span style="font-size:12pt;">&#160;</span><br><span style="font-size:12pt;"><b><span style="font-size:10pt;">OTHER QUALIFICATIONS</span></b><span style="font-size:10pt;">:&#160; Requires written and verbal communication and interpersonal skills.&#160; Ability to communicate and interact with individuals at all levels of responsibility.&#160;</span></span></span><br><br>This position is based in South San Francisco, CA. The expected salary range for this position is $190,000 - $225,000 , plus comprehensive benefits and equity. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training.<span style="font-family:Arial, Helvetica, sans-serif;"><span style="font-size:12pt;"><span style="font-size:10pt;"> </span></span></span><br>&#160;