Job DescriptionPrimary Function of Position:Responsible for ensuring suppliers meet ISI requirements for cost, quality, delivery and service. Drive suppliers to continuously improve business and manufacturing processes. Evaluate and collaborate on supplier selection with cross functional partners. Supports sustaining production, monitors and engages with suppliers to improve supplier performance.
Roles & Responsibilities:- Select, evaluate, and qualify suppliers
- Part qualification including pFMEAs, FAIRS, Cpk, and Control Plans
- Supplier Corrective Action Request initiation, execution, and closure
- Ensure compliance to quality management system and regulatory requirements by leading and mentoring auditors for QMS audits
- Partner with global supply chain to optimize the supply base
- Drive suppliers to continually improve their business and manufacturing process performance to meet Intuitive Surgical requirements for supplier excellence including ship to stock programs using a collection of best practices in project management, Six Sigma, Lean, SPC and negotiation
- Utilize data-driven decisions to evaluate supplier part cost, delivery, quality, capacity and capability. Apply metrics to measure real improvement and judge required intervention or change at the supplier or in a commodity.
- Drive corrective actions for supplier process by driving suppliers to true root cause analysis and corrective and Preventive actions.
- Provide effective and timely supply base health information to management
- Prepare and deliver supplier communications as required by working with suppliers on scorecard creation of QBRs, Supplier Summits, etc.
- Manage the ASL and Global Commodity Matrix
- Influence and guide Engineering in choosing suppliers by determining selection criteria for preferred suppliers and leading the team effort to evaluate preferred suppliers.
- Deliver the following Quality deliverables: pFMEA, Special Process Validations, FAI, and Cpk by leading suppliers through the pFMEA development, judging process validation requirements and signing-off on protocols as ISI rep, judging process capability with supplier as well as judging FAI suitability.
- Develop the supplier business continuity / disaster recovery plans by managing suppliers to create plans, judge plans for risks and negotiate with suppliers to reduce risks. Identify and investigate opportunities for cost reduction and/or quality improvement by judging opportunities and creating strategies to seize those opportunities, completes research and provides data-driven plans to management.
- Review, analyze and close customer complaints, manufacturing variance requests, and first article inspections by judging risk analyses and justifications, determining corrective and preventive actions at suppliers, looks for opportunities with suppliers to eliminate recurrence.
QualificationsSkills, Experience, Education, & Training:- BS degree in Engineering or equivalent, experience in catheter development preferred
- Minimum 5 years related experience in Supplier Engineering/Development/Quality or related field
- Excellent written and verbal communication skills including presentations to executive level management
- Excellent Interpersonal skills and team building skills
- A proven history of implementing Lean/6 Sigma/SPC Programs at suppliers
- Excellent Project Management skills
- Excellent analytical and problem solving skills along with good judgment
- Demonstrable knowledge in evaluating and challenging supplier technical, quality, and business capabilities
- Demonstrable knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost and capacity (specialization can be in metal fabrication, plastics, electronics, and/or contract manufacturing)
- Excellent knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards)
- Significant computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP
- CAD experience with 3D modeling tools is a plus
- Proven ability to motivate suppliers
- Experience in a high-volume medical device company is a plus
- Ability to read and interpret detailed mechanical drawings and communicate technical information
- Ability to travel to suppliers on an as needed basis - domestic and international
Additional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate's qualifications, consistent with applicable law.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
