Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Senior Supplier Quality Engineer
This is a Remote position, central or southeast preferred
Manage supplier qualification processes, conduct comprehensive audits, and implement continuous improvement initiatives. You'll work with cross-functional teams to resolve quality issues, implement corrective actions, and maintain strong supplier relationships. Your expertise will be essential in developing and maintaining supplier quality metrics, managing quality agreements, and ensuring compliance with industry standards and regulations.
Manage supplier performance, guide quality improvement projects, and contribute to new product introductions. You'll have the opportunity to support team development while working with a global network of professionals dedicated to excellence in quality management.
Education/Experience:
Advanced degree plus 3 years of experience, or bachelor's degree plus 5 years of experience in supplier quality management within regulated industries (medical device, pharmaceutical, or similar)
Preferred Fields of Study: Engineering, Science, Manufacturing, Operations, or related technical field
Quality Lead Auditor certification preferred
ASQ Certified Supplier Quality Professional (CSQP) or Quality Engineer (CQE) desired
Knowledge, Skills, Abilities:
Six Sigma Green Belt or higher certification advantageous
Comprehensive knowledge of quality management systems and regulatory requirements (ISO 13485, ISO 9001, 21 CFR Part 820, MDSAP)
Proven expertise in quality tools and methodologies (FMEA, 8D, PPAP, APQP, SPC)
Strong proficiency in statistical analysis and quality management software
Experience with mechanical, electro-mechanical, and packaging commodities as well as quality-related services
Experience with supplier audit programs and CAPA management
Excellent project management and problem-solving capabilities
Clear written and verbal communication skills
Demonstrated ability to build and maintain relationships with internal and external stakeholders
Proficiency in Microsoft Office Suite and quality management systems (e.g. SAP, TrackWise)
Ability to travel up to 10-15% for supplier audits and quality management activities
Strong analytical and data-driven decision-making skills
Experience coordinating cross-functional teams and implementing continuous improvement initiatives
Ability to manage multiple priorities effectively
