Supplier Quality Engineer
Position Overview
The Supplier Quality Engineer is responsible for ensuring supplier compliance with regulatory and quality standards through audits, monitoring, and continuous improvement initiatives. This role partners closely with suppliers and internal teams to investigate quality issues, implement corrective actions, and enhance overall supplier performance. The ideal candidate brings experience in FDA-regulated manufacturing environments, strong supplier management skills, and a proactive, problem-solving mindset.
Key Responsibilities
Conduct regular supplier audits to ensure compliance with regulatory and quality requirements
Monitor, evaluate, and improve supplier quality and process performance
Lead and participate in on-site supplier visits for root cause analysis
Implement, verify, and track corrective and preventive actions related to supplier quality issues
Develop, maintain, and present supplier quality performance metrics
Maintain accurate and complete quality records related to supplier management
Support and lead initiatives to improve the Quality Management System (QMS), including coordination, development, training, and maintenance
Review customer complaints, conduct product investigations, and ensure timely and effective complaint closure
Perform medical device reporting (MDR) assessments and support potential MDR submissions
Develop sampling plans and analyze quality and reliability data
Drive continuous improvement efforts focused on product quality and manufacturing processes
Qualifications
5+ years of experience in a manufacturing quality role within an FDA-regulated or equivalent industry
Experience in supplier quality management required
Medical device industry experience strongly preferred
Working knowledge of FDA regulations, cGMP, 21 CFR Part 820, and ISO 13485:2016
Strong analytical, problem-solving, and decision-making skills
Proficient in Microsoft Office applications
Excellent communication, interpersonal, and teamwork skills
Ability to travel up to 30%
Education
Bachelor’s degree in Engineering preferred
FootBridge is an equal opportunity employer committed to an inclusive environment where everyone is valued and respected. We make employment decisions based on qualifications and business needs, without discrimination on any basis, and we welcome candidates from diverse backgrounds to apply.
