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, ISO14001 & OSHAS18001).

• 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