Supplier Quality Engineer

Job Title

Job Description

Job Responsibilities:

• Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.
• Support internal and supplier root cause investigations and CAPA. Drive corrective actions for supplier process by driving suppliers to true root cause analysis and corrective and Preventive actions
• Manage and escalate supplier issues when intervention or a change at a supplier is necessary. Plan, execute, report and follow-up on supplier quality system audits
• Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.
• Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
• Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.
• Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision.
• Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects.
• Utilize analytical and problem-solving skills to develop and optimize supplier performance working in conjunction with the Worldwide Supplier Quality Management Team.
• Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Lead discussions to drive resolution.
• Collaborate with operations and franchise operations development on process/product improvement projects.
• Prepare Supplier Quality Agreements and drives discussion with supplier while consulting Supplier Quality Manager.
• Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts
• Lead component qualification change projects in collaboration with key business partners and the supplier's applicable functional groups.
• Apply appropriate Quality Engineering and PEx tools (e.g. PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) to support innovations and continuous improvements
• Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO
  14001 & OSHAS
  18001).
• Responsible for communicating business related issues or opportunities to next management level
• Other duties as assigned

Required Qualifications:

• Bachelor's degree in Engineering or a related field
• 5 years Supplier Quality and/or Supplier Development
• Understanding of 21 CFR 820, ISO 13485, and ISO 14971 requirements
• Prior Supplier Quality experience in a manufacturing plant or technical background
• Working experience in good manufacturing practice regulated environment is preferred (medical device, pharmaceutical, etc.)
• Demonstrated knowledge of manufacturing principles and practices, and procedures
• Direct experience in plant and/or supplier GMP auditing
• Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA/SCAR systems and investigations, production and process controls
• Experience with documentation and technical writing skills, in a regulated compliance environment
• Demonstrated ability to identify compliance risks and assess business impact
• Ability to manage complexity and lead critical discussions
• Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches
• Bilingual Spanish English
• Prior experience with FDA inspection

Preferred:

• Advanced Degree
• Certified Lead Auditor is a plus (ISO 13485)
• New product introduction experience
• Broad knowledge of QS Regulations and Supplier Management principles

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the…