Auris Health, Inc., is an early stage venture-funded medical device company. We are developing a next generation robotic platform to address a variety of surgical applications. Candidate will be responsible for providing quality engineering support for new product commercialization and process development. The ideal candidate should have experience supporting new product introduction and manufacturing of novel catheter delivery systems and innovative instruments. This individual will work with engineering teams within the company as well as contract manufacturers and suppliers to ensure product quality and will provide new product development design assurance as needed. This position requires knowledge of medical device regulatory environment (FDA, MDD, ISO 13485). Candidates should also have knowledge to support design control, testing, and risk management, ISO 14971. This individual will serve as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
- Will provide quality engineering to support the design and manufacturing of novel catheter delivery systems innovative instruments and accessories for minimally invasive procedures.
- Evaluates and participates in the selection of suppliers and contract manufacturers. Works closely with contract manufactures to ensure product quality. Monitors supplier performance, through collection and trending of data and performing supplier quality audits, as required.
- Reviews, approves and generates Engineering Change Notifications (ECNs) in addition to nonconformance records (internal/external) to determine: disposition, root cause and need for corrective and preventive actions.
- Provide technical guidance and training to team members in QA Engineering areas of expertise and compliance.
- Supports internal and external audits.
- Perform other duties as assigned by the Quality Management team.
- Education and/or experience equivalent to a bachelor's degree in Mechanical Engineering, or a related field with 5-7 years quality engineering experience.
- Experience supporting the manufacture and design of novel catheter delivery systems and innovative instruments is highly desirable.
- Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member.
- Proven ability to work effectively in a team environment through conflict resolution and negotiations.
- Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards.
- Experience handling NCRs, deviations, investigations and CAPAs preferred.
- Working knowledge of statistical methodologies, quality control and manufacturing tools, such as applied statistics, lean manufacturing, Six Sigma, etc.
- Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs. Experience with SAP is desirable.
- Medical device experience or equivalent experience in a regulated industry preferred.
- Certification as a ISO 13485:2016 auditor/lead auditor
- ASQ certification