Senior Quality Engineering Manager

Verb Surgical - a Google and Johnson & Johnson joint venture!

Mission:

Our Quality Leader 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 highly talented quality engineers 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. The Quality Leader provides coaching and mentoring to engineers and other project team members on the Quality Management System and compliance to external standards.

• Work with Product Development, Manufacturing/NPI, Quality & Purchasing teams to develop and execute Quality Engineering activities to meet commercial milestones
• Support the analysis and evaluation of business situations, production capabilities, manufacturing problems, and the design and development of new products from the quality assurance perspective.
• Suggest alternative methods and procedures in solving problems and meeting quality requirements.
• 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.
• Ensure maintenance of and compliance to the most recent versions of all applicable international quality system and product quality standards.
• 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, FMECA, 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 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 Verb SOPs.
• Review and draft process validation plans and protocols, and conduct validation testing of new or updated products and equipment, fixtures or tools as necessary.
• 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, nonconforming materials, product lot release testing, and finished goods control. Identify and develop test methods and fixtures as needed.
• Participate in internal audits for quality systems, processes, and products to ensure compliance with regulations and internal specifications.

• Technical, Computer and Practical Skills
• Through applied knowledge of ISO 13485, ISO 14971, IEC 60601 standards and 21 CFR 820 and MDD regulations.
• Fluent in a wide variety of Quality tools such as 8D, 6S, 5 Why Analysis processes.
• Word processing, spreadsheet, Internet, e-mail, manufacturing, statistical and database software including Minitab and ReliaSoft applications.
• Working knowledge of statistics for R&D, quality, reliability and inspection.
• Comfortable and effective in a startup environment.
• This position requires excellent verbal, written (English) and interpersonal communications skills with proven ability to translate technical information into effective procedures, plans, specifications and agreements.
• Ability to effectively present information in one-on-one and small group situations to supplier personnel, partners, consultants and employees at all levels of the organization.
• Ability to read, analyze, and interpret applicable scientific and technical journals, and legal documents. Ability to respond to common inquiries from auditors, notified bodies, regulatory agencies, or members of the business community.

• 8+ years of experience in a quality engineering role in the medical device industry with experience in complex systems strongly preferred. 2+ years in a manager role.
• B.S. or higher in Biomedical, Electrical, Mechanical or Systems Engineering or equivalent relevant work experience. Graduate degree preferred
• Exceptional working knowledge of Design Controls and External Standards applicable to complex medical device products.
• Strong understanding of human factors and usability engineering.
• 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.