Director of Quality
ReShape Lifesciences has a Director of Quality position available in our San Clemente office. This role is responsible for strategic direction, planning and deployment of the ReShape Lifesciences quality functions to achieve corporate objectives. The position collaborates with senior management staff and all personnel throughout the company on a strategic level to anticipate and prepare for current and future Quality needs.
ESSENTIAL JOB FUNCTIONS (including but not limited to):
- Provide direction and oversight for the ongoing management of the Quality System.
- Prepare the company for future changes in regulations and standards.
- Support the Product Development function by appropriate allocation of Quality Engineering resources for the purpose of product development and field support.
- Team with the operations leadership team to develop and implement strategic supplier management, including selecting, approving and maintenance of suppliers, including supplier quality plans, process plans and validations.
- Direct Quality Control and Quality Assurance functions to ensure product quality and continuously improve both product and process quality.
- Act as primary contact for FDA and Notified Body quality system audits.
- Support the Regulatory function by implementing appropriate compliance strategies, assembling submission documentation and technical files.
- Provide systems for the collection, analysis and communication of quality data.
- Support research activities by providing a Quality Assurance Unit (QAU) function for GLP studies.
- Owner of Corrective and Preventative Action (CAPA) system with facilitation with respective business functions.
- Responsible for planning, scheduling, and preparing Management Review based on established frequency schedule.
- Bachelor’s Degree is required (Business, Science or Engineering)
- Class III implantable medical device experience required
- Management experience required
- Experience leading quality organizations supporting regulatory, product development, purchasing and/or production functions in addition to a background in quality systems, including implementation of ISO 13485, design dossiers, technical files, IDE and PMA Application support, and FDA QSR compliant systems
- Additional experience in operations, engineering, supplier relations, inspection and test, auditing product development required