Senior Supplier Quality Engineer - Tactile Medical
New Brighton, MN 55112
About the Job
Overview:
The Senior Supplier Quality Engineer is responsible for managing and ensuring the quality and compliance of suppliers. This includes conducting supplier audits, maintaining the Approved Supplier List (ASL), monitoring supplier performance through metrics, and overseeing supplier-related quality activities to ensure that all products and materials meet regulatory requirements and internal quality standards. Must be able to demonstrate understanding of medical device regulations (ISO 13485, 21 CFR 820, etc.).
Responsibilities:- Develop and maintain quality systems, processes, and procedures related to supplier quality management.
- Plan, schedule, and perform regular supplier audits to ensure compliance with company quality standards, regulatory requirements (e.g., ISO 13485, FDA), and contract specifications.
- Manage the supplier corrective action system by reviewing and prioritizing SCAR requests for completeness, coordinating SCAR tasks as appropriate, and compiling SCAR metrics for reporting.
- Track and analyze supplier performance using established metrics. Report on supplier performance to management, recommending corrective actions when necessary.
- Oversee and manage the ASL, ensuring that all suppliers are properly evaluated and qualified according to regulatory and company standards.
- Review and approve new suppliers, re-qualify existing suppliers, and ensure the timely update of supplier records.
- Maintain accurate documentation related to supplier qualifications, audits, corrective actions, and performance metrics.
- Support the Supplier Management process in electronic Quality Management System by performing administrative tasks such as; coordinating supplier change evaluations, maintaining current supplier information, and recording results of metrics review.
- Ensure supplier evaluation and monitoring processes meet quality system requirements and company policies.
- Maintain and support administrative functions in quality management system software supplier modules as necessary.
- Other duties as assigned.
Required:
- Bachelor’s Degree or an equivalent combination of education and work experience.
- 5+ years of experience in supplier quality management, supplier audits, or quality assurance, preferably within the medical device or regulated manufacturing industries.
- Experience with ISO 13485, FDA QSR, and other regulatory requirements for medical devices.
- Lead auditor certification through an accredited organization (e.g. ASQ, notified body, etc.).
- Ability to travel to supplier locations for audits and assessments (approximately 20% of the time) including internationally.
Preferred:
- Proficiency with Netsuite or other ERP Software
- Experience with Grand Avenue Software
- CSQP or related certification
- Six Sigma belt certification
Source : Tactile Medical