Manager, Supplier Quality Engineering

Manager, Supplier Quality Engineering
Verb Surgical - a Google and Johnson & Johnson joint venture!

Mission of the Role (What contributions does the position make for the company?):

Lead the effort to drive exceptional product quality, safety, reliability throughout the Verb Surgical supply chain. Establish world class supplier quality processes and metrics. This individual will manage a team of engineers and specialists in Supplier Quality, Incoming Quality, and Metrology functions. This important technical management position will have direct influence on component, assembly and final product quality for R&D and Production builds. Plan, direct and coordinate activities including pFMECAs, supplier risk assessments, qualifications, supplier audits and efforts to monitor and improve supplier quality.

Key Interfaces:

• Interact on a daily basis with R&D, Manufacturing/NPI, Quality and Purchasing resources as well as Suppliers and Development Partners to drive quality and exceptional supplier performance.

Key Responsibilities:

• Work with Product Development, Manufacturing/NPI, Quality & Purchasing teams to develop and execute Supplier Management activities to meet commercial milestones
• Identify capable suppliers, qualify as necessary, and work closely with supplier to define and validate processes. Define product design and tooling to ensure efficient, repeatable and cost effective production methods
• Draft, manage and implement supplier/engineering changes, process controls and quality plans that drive quality and process capability into supplier manufacturing
• Accurately track equipment, fixtures and tools as well as materials on open POs related to supplier delivery commitments, including work-in-process (WIP)
• Transfer knowledge of special supplier processes and associated assembly techniques to Verb team and mentor and train fellow supplier quality engineers
• Provide technical guidance mentoring for identifying and resolving issues from suppliers

Work with suppliers/partners to:

• Ensure that supplier processes adhere to Verb's QMS requirements and any agreements between the parties as applicable
• Conduct supplier audits and collaborate with suppliers to develop appropriate corrective/preventive actions to ensure delivery of high-quality products
• Lead Manufacturing, DFX and NPI design reviews together with suppliers and Verb personnel and provide feedback for improvements
• Ensure production line readiness for proto and pilot builds at suppliers/CMs and resolve technical, quality and yield issues
• Manage suppliers across various commodities including complex electro-mechanical assemblies, motors, actuators, encoders, optics, imaging electronics, PCBAs, molded plastics, machined components, cables and other engineered materials/components
• Train and mentor supplier personnel on best practices in quality systems, process and controls methods, problem solving and statistical tools
• Lead a team of supplier quality engineers and quality inspectors, manage team performance, and conduct regular review and assessment.

Draft, develop and refine processes for:

• Supplier Management to ensure supplier quality and suitability as well as reliability and competitive pricing of supplied parts
• Increased yield and consistency of manufactured components
• First Article Inspection (FAI) process, plans and procedures for suppliers and partners
• Incoming inspection and acceptance/test procedures for supplier parts/assemblies

Other responsibilities:

• Conduct tolerance stack-up analysis and pFMECAs where applicable
• Maintain accurate tracking data related to supplier performance, quality, audits, delivery and certifications including IQC failures, NCMRs, late deliveries
• Analyze and report on supplier quality metrics and drive improvement measures
• Assign, track, and approve Supplier Corrective Action Requests
• Apply statistical methods to estimate supplier process capability/potential (Cp, Cpk)
• Resource planning and management
• Grow, develop, and mentor direct reports

How will the position evolve over time?

This person will be responsible for hiring the team and building the suppler quality and IQC functions and will work with other cross-functional teams to further refine the supplier management process and continue to build up Verb quality system. As the company grows there may be opportunities for advancement and increased responsibility.

Competencies:

• Technical and Practical knowledge
  • Familiar with JIT, DFX, SFDM and lean manufacturing processes and a variety of Quality tools such as 8D, 6S, 5 Why Analysis processes
  • IPC-600/610, 2200 series, ISO 9001 and/or ISO 13485 and ESD standards
  • WEEE and RoHS/REACH compliance
  • Comfortable and effective in a startup environment
• Language ability
  • 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.

• Reasoning and Technical Ability:
  • Attention to detail required. Ability to define problems, collect data, establish facts, and draw valid logical and/or statistical conclusions. Ability to read and interpret engineering drawings and component specifications.
  • Excellent project and time management skills

Experiences and Qualifications (include Years of Experience, Leadership, Industry, etc.):

• 7+ years of experience in manufacturing/engineering/quality engineering with a minimum of 5 years in supplier quality; medical device industry experience strongly preferred
• Experience setting up and managing Supplier Quality and Supplier Management processes
• Experience in communicating key product characteristics to suppliers and supporting implementation of quality assurance methods to control key process parameters at suppliers (DFX, VAVE, SPC, Gage R&R, pFMECA, etc.)
• B.S. or higher in Biomedical, EE, or ME preferred or equivalent relevant work experience
• International experience with multi-cultural awareness preferred.
• Supplier Auditor/Internal Auditor certification a plus.

Travel: Up to 40%, but likely less
Physical Demand: No physical demands required.

Who is Verb Surgical?

Verb Surgical™ is shaping the future of surgery. A new future, a future unimagined even a few years ago, which will involve machine learning, robotic surgery, instrumentation, advanced visualization, and data analytics. A future of surgery that aims to achieve improved patient outcomes, lower costs, and greater hospital efficiency.

Verb Surgical was founded with technology, expertise, and funding from Verily (formerly Google Life Sciences) and Ethicon, a medical device company in the Johnson & Johnson family of companies. This company will continue in strong partnership with Verily and Johnson & Johnson (Google and Johnson & Johnson Team for Robotic Surgery) to advance the surgical tools and capabilities available to surgeons and OR professionals today.