Supplier Quality Engineer

Overview

Supplier Quality Engineer responsible for monitoring and resolving supplier quality issues, evaluating supplier performance, and maintaining supplier qualification and quality documentation.

What you'll do

• Monitor and work supplier quality issues directly with the manufacturer and communicate status on non-conforming parts/suppliers across all programs.
• Evaluate supplier performance and determine appropriate inspection processes; provide guidance to the Receiving Inspection function at the site level.
• Perform the supplier qualification process and activities for new suppliers, changes and exits.
• Ensure maintenance of supplier qualification and supplier re-evaluation documentation.
• Release and maintain the Approved Supplier List.
• Support audit requests by providing supplier quality data and supplier points of contact to the Supplier Audit team.
• Lead and execute supplier risk assessments (e.g., as a result of supplier audit or SQA refusals, poor performing suppliers, supplier qualification and re-evaluation).
• Lead and execute Supplier Quality Agreements (new creations, sustaining).
• Maintain the Quality Record retention process and the controlled documentation system.
• Maintain SharePoint and databases related to the Supplier Qualification process and Scorecard dashboard.
• Perform analytics and data reporting to support supplier metrics, dashboards and supplier and quality management reviews, internally and with customers.
• Ensure compliance with cGMP, EN ISO 13485, 21 CFR 820/201/211, EuGMP and FDA/regulatory requirements for the Quality System.
• Support regulatory, customer, and internal inspections/audits; act as SME for Supplier Qualification, re-evaluation process and ASL management activities.
• Implement corrective actions as needed related to the Supplier Qualification process.
• Support all company safety and quality programs and initiatives, and ensure compliance with learnings from GMP training events.
• Serve as the focal person for commodity-related quality and functional issues stemming from purchased components, and ensure production-critical supplier issues are resolved in a timely manner.
• Serve as the point of contact for Inspection Plans and Inspection Methods, and provide guidance to Receiving Inspection Auditors.
• Ensure ongoing site supplier evaluation using data from Receiving Inspection, MRB, Customer Returns, SCAR database and customer work cells; report performance internally, to the supplier, and to the customer where applicable.
• Perform supplier audits interfacing with Corporate SQE if applicable.
• Provide documentation to perform inspection of components per Inspection Plans in SAP.
• Monitor and drive PPM issues with the supply base and help suppliers achieve "Dock to Stock" certification with Jabil.
• Drive supplier selection strategies that yield a supply base usable across all customer programs, providing leverage for cost savings.
• Proactively communicate information or issues that may impact product costs or manufacturability to all affected departments.
• Adhere to all safety and health rules and regulations, and comply with company security policy.

What you'll need

• Bachelor's degree required.
• 3 to 4 years of experience in a similar role, ideally in a regulated environment, or in Manufacturing Engineering; or equivalent combination of education and experience.
• Advanced PC skills, including training and knowledge of Jabil's software packages.
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to effectively present information to top management, public groups, and/or boards of directors.
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
• Ability to apply concepts of basic algebra and geometry.
• Ability to work with mathematical concepts such as probability and statistical inference.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Minimum language required: English and German.

Nice to have

• Bachelor's degree in Engineering.

Details

• Location: Remote, India.
• Physical demands: may be required to sit, stand, walk regularly, and occasionally lift up to 15 lbs; must be accessible to production floor and office staff; frequent reading of documents and use of computer monitor.
• Work environment: primary workstation in the office area with some time each day on the manufacturing floor; noise level low to moderate.