Auris Health, part of Johnson and Johnson Robotics and Digital Solutions, is recruiting for Director, Quality Engineering, Flexible Robotics located in Santa Clara, California.
Auris Health, Inc., part of the Johnson & Johnson family of companies, is transforming medical intervention. By combining advancements in medical robotics, instrumentation, navigation and data science, Auris is building a platform technologies capable of expanding the applicability of robotics to a spectrum of medical procedures. Learn more about Auris Health at https://www.aurishealth.com/.
Our Director, Quality Engineering, Flexible Robotics will drive exceptional product quality, safety, design and reliability through the R&D/Product Development and Quality teams and into the product. This important technical position will have direct influence on component, assembly, and final product quality for R&D and production builds and release to market. This individual will manage a team of 25-30 engineers, technicians, specialists and managers and will actively participate in risk management, design concepts, design specifications, design for quality and manufacturing requirements, process/technology development, product verification/validation, project planning, and associated documentation.
Work with Product Development, Manufacturing/NPI, Quality & Purchasing teams to develop and execute Quality Engineering activities to meet program objectives
- Provide leadership in design and implementation of world-class quality systems to support the entire product life cycle with focus on business results including reduced cycle time, and lower COGS (Cost of Goods Sold), prevention, detection of defects at earliest phase of product design, continuous improvement and customer satisfaction. Review technical problems and departmental procedures and recommends solutions to problems or changes in procedures.
- Provide authoritative guidance on ISO, QSR and external standards requirements to the new product development teams.
- Lead Risk Management efforts in accordance with ISO 14971 and Design Control efforts in line with ISO 13485 and 21CFR 820.
- Train and mentor engineers and other project team members on best practices in quality engineering and regulatory compliance to external standards.
- Work with Quality and Regulatory Teams to ensure maintenance of and compliance to current versions of all applicable international quality system and product quality standards including product stewardship, cybersecurity, and product security requirements. Support the regulatory submission process in compliance with MDD/MDR, FDA, and other select country regulations and requirements by analyzing data, interpreting regulations, and assisting in the completion of submissions as required.
Champion processes covering Quality Engineering and Quality Management to:
- Train, support, and encourage team members in the use of quality tools such as root cause analysis, risk analysis, FMEA, DOE, and statistical methods.
- Provide guidance about Six Sigma principles (Sampling, Acceptance, DOE, Statistical Process Control, Root Cause Analysis, FTA, control charts, capability analysis).
- Participate in designing and writing plans and protocols for testing of complex electromechanical capital, consumable, and reusable medical device products including software with R&D team.
- Develop and execute verification and validation plans and protocols associated with product/process quality according to FDA and ISO regulations and Auris SOPs.
- Assist in the development, improvement, and management of product assurance systems such as receiving quality assurance, in-process quality assurance, statistical process control, calibration / preventative maintenance, non-conforming materials, product lot release testing, and finished goods control. Identify and develop test methods and fixtures as needed.
- Participate in internal and external audits for quality systems, processes, and products to ensure compliance with regulations and internal specifications.
- Bachelor’s Degree in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent is required; Advanced degree is preferred
- A minimum of 10 years of experience in a quality engineering role in the medical device industry with experience in complex medical device systems is required
- A minimum of 5 years in a manager role or people leadership, manager of managers is preferred
- Certifications such as CQE (Quality Engineer Certification), CRE (Reliability Engineer Certification), CQA (Quality Auditor Certification), CQM (Certified Quality Manager), or PE Certification is strongly preferred.
- Exceptional working knowledge of Design Controls and External Standards applicable to complex medical device products is required.
- Lead Risk Management efforts in accordance with ISO 14971 and Design Control efforts in line with ISO 13485 and 21CFR 820 is required
- Strong understanding of human factors and usability engineering is preferred.
- International experience with multi-cultural awareness preferred.
- Working knowledge of biocompatibility and sterilization validation is a plus.
- UDI labeling, WEEE and RoHS/REACH compliance knowledge is a plus.
- This position will be located in Santa Clara, CA and may require up to 25% domestic and international travel
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-California-Santa Clara-
Verb Surgical Inc. (6270)