6 + months
- Supplier Quality management background. Lead auditor qualification is an advantage.
- Responsible for Quality metrics preparation and reporting, including metrics for Supplier performance.
- Participate in developing and executing mitigation strategies to reduce risk associated with critical and high-risk suppliers.
- Play an active role in Supplier management program by identifying the quality system needs for qualifying and monitoring suppliers.
- Investigate and interpret internal or external Quality and Regulatory requirements and recommend best practices to the organization.
- Experience with Quality Systems with Medical Devices
- Knowledge of regional and international quality system requirements including 21 CFR 820, CFR Part 11, ISO 13485 for Medical Devices
- Must have a strong understanding of quality system requirements and how each quality system element connects to another.
- Proficient in Microsoft Office applications.
- Strong technical and problem-solving foundation
- You work independently as well as collaboratively with cross functional teams.
- Clear and professional communications to all levels of the organization are important in this role and you will have well-developed written and oral communication skills.
- You possess a positive, can-do attitude with an underlying belief that failure is not an option.
Remote: Supplier Quality – Software Configuration Vendors – Medical Device (233280)