Intuitive Surgical Careers
Senior Supplier Quality Engineer
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 181759
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Primary Function of Position:
Sr. Supplier Quality Engineer will provide expertise and support to run efficient, effective and sustainable processes to ensure ongoing quality with international and domestic regulations and standards pertaining to supplier and purchasing controls. S/he will work with cross-functional organizations (Purchasing, Quality and Engineering) to improve business and supplier quality processes. Additionally, s/he will lead internal and external CAPAs (related to supplier controls), perform supplier evaluations, lead and present data at the Supplier Monitoring Board, and manage the Approved Supplier List (ASL).
Roles and Responsibilities:
This position has responsibility and authority to:
• Establish and continually improve the procedures and processes related to Supplier Controls in adherence with the latest International and Domestic regulatory standards.
o Strategically plan to add, remove and optimize procedures and work instructions to support the business and supplier quality processes.o Conduct training classes both internally and externally to ensure compliance with procedural changes.
• Coordinate and manage harmonization of procedures and work instructions between ISI Corporate and ISI Remote sites.Qualifications
• Proactively identify and anticipate risks to ISI QMS caused by supplier non-conformances; take appropriate actions to address and resolve.
• Initiate and lead Corrective and Preventive Actions teams both externally (SCAR) and internally (CAPA) for non-conformances related to supplier and purchasing controls.
• Drive suppliers to implement continuous improvement programs that meet requirements defined by ISI. Use continuous improvement best practices in project management, Six Sigma, Lean, SPC and negotiation tactics. The senior engineer will drive these improvements with minimal managerial guidance at several suppliers simultaneously.
• Initiate and perform supplier evaluations as Lead Auditor. Resolve and archive all associated documentation associated with the evaluation.
• Perform oversight guidance to contractors who are performing supplier evaluations on behalf of ISI.
• Gather supplier quality data and continuously monitor KPIs. Lead monthly and quarterly Supplier Monitoring Boards to present the metrics analysis, and actions taken to address data trends.
• Ensure high data integrity on the Approved Supplier List. Review and approve supplier promotions and demotions. ASL changes may require on-site evaluations or other in-depth data reviews to ensure the supplier is compliant to ISI standards.
• BS degree in Engineering or equivalent, MS degree preferred.
• Minimum 10 years related experience in Supplier Quality Engineering or related field.
• In-depth knowledge of 21 CFR part 820 and ISO 13485.
o Extensive experience with auditing suppliers to these standards;
o Certified Lead Auditor preferred, but not required.
• Ability to be a true team player and a partner to the cross functions teams; be part of the solution and demonstrate ability to use sound judgment in implementing practical QMS solutions.
• Critical thinking skills and a passion to work in a fast-paced industry with complex and innovative technology.
• Strong organizational, written and verbal communication skills and the proven ability to prioritize tasks effectively in a deadline-driven environment. Written and verbal skills include presenting complex data and strategies to executive management.
• Experience in Lean and 6 Sigma is preferred, but not required.
• Proven and demonstrated leadership and Project Management skills.
• Proven and demonstrated ability to evaluate complex supplier capabilities especially related to QMS and technical depth.
• Experience with completing PPAP or PPQP processes preferred.
• Expert computer experience with Windows, MS Office, Agile, SAP and Mini-Tab (or other SPC analysis tool).
• Experience in a high-volume medical device company is preferred.
• Domestic and international travel will be approximately 20% per quarter.