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.

• 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.

• 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

• 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.

• 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

• 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

• 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

• 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.