Supplier Quality Engineer

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee and address supplier quality concerns directly with manufacturers.

• Relay updates regarding non-conforming components and suppliers across various programs.

• Assess supplier performance and establish suitable inspection procedures.

• Offer support to Receiving Inspection at the site level.

• Manage controlled documentation, record retention, and information services processes.

• Prepare and evaluate GMP, procedures, quality control, engineering, manufacturing, change authorization, and form documentation.

• Conduct supplier qualification activities for onboarding new suppliers, as well as changes and exits.

• Maintain documentation for supplier qualification and re-evaluation.

• Release and uphold the Approved Supplier List.

• Assist with supplier audit requests by providing quality data and supplier contacts.

• Lead supplier risk assessments and manage Supplier Quality Agreements.

• Oversee quality record retention processes, SharePoint, databases, and supplier scorecard dashboards.

• Deliver analytics and reporting for supplier metrics and management reviews.

• Ensure adherence to cGMP, EN ISO 13485, 21 CFR 820/201/211, EuGMP, and FDA/regulatory standards.

• Support regulatory, customer, and internal inspections and audits as the subject matter expert in Supplier Qualification and ASL management.

• Implement corrective actions related to supplier qualification.

• Promote company safety and quality initiatives and ensure GMP compliance.

• Act as the main contact for commodity-related quality and functional concerns.

• Resolve supplier issues critical to production and ensure corrective measures are put in place.

• Provide guidance on inspection plans and methods to Receiving Inspection Auditors.

• Conduct ongoing evaluations of site suppliers using Receiving Inspection, MRB, Customer Returns, SCAR, and customer work-cell data.

• Collaborate with Corporate SQE for supplier audits.

• Offer documentation for component inspections according to SAP inspection plans.

• Track and address supplier PPM issues and support Dock to Stock certification.

• Develop supplier selection strategies for customer programs to achieve cost savings.

• Communicate issues that impact product costs or manufacturability to relevant departments.

• Adhere to safety, health, security, quality, and company protocols.

⛳️ Requirements

• A Bachelor's degree is required; a degree in Engineering is preferred.

• 3 to 4 years of experience in a related role, preferably within a regulated environment or Manufacturing Engineering, or an equivalent mix of education and experience.

• Proficient PC skills, including familiarity with Jabil’s software applications.

• Capability to read, analyze, and interpret common scientific and technical publications, financial statements, and legal documents.

• Ability to address common inquiries or complaints from customers, regulatory bodies, or business community members.

• Proficient in effectively presenting information to senior management, public groups, and/or boards of directors.

• Skill in calculating figures and amounts involving discounts, interest, commissions, proportions, percentages, area, circumference, and volume.

• Capability to apply basic algebra, geometry, probability, and statistical inference.

• Skill in defining problems, gathering data, establishing facts, and drawing valid conclusions.

• Ability to interpret extensive technical instructions presented in mathematical or diagrammatic form and manage both abstract and concrete variables.

• Proficiency in the English language is required.

• Proficiency in the German language is required.

• Ability to sit, stand, and walk regularly, with occasional lifting of up to 15 lbs.

• Capability to access the production floor and interact with office staff while using necessary office equipment.

• Ability to frequently read written documents and utilize a computer monitor.

🏝️ Benefits

• Equal opportunity employer.

• Reasonable accommodations available for qualified individuals with disabilities.