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Quality Inspector
3 months ago
Saluda is a global healthcare company that is redefining Spinal Cord Stimulation (SCS) therapy at the intersection of advanced AI, real-time diagnostics, and ground-breaking clinical evidence. Every day at Saluda, we are focused on the dignity of responsibility to elevate human health and optimize clinician operations by unlocking the power of data and science to reach patients in need.
At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt. With the passion and energy of an accomplished team of seasoned experts, our focus is to revolutionize the standard of care in the neuromodulation space by transforming the lives of patients suffering from debilitating pain.
The Quality Control (QC) Inspector will report to the Director of Quality. The QC Inspector is responsible for performing quality control inspections and reviews to confirm that product is acceptable for release for distribution.
Accountabilities and Associated Responsibilities:
- Perform quality control inspections in accordance with revision-controlled quality system procedures.
- Review results of manufacturing, including product sterilization load parameters, test results and identify nonconformances.
- Complete required documentation in accordance with Good Documentation Practices to record results of inspections.
- Collaborate with Engineers and Supply Chain to initiate, contain, investigate and manage nonconformances. Support the nonconformance process through final disposition.
- Manage product microbial testing, including sampling, in accordance with established procedures.
- Comply with applicable regulatory requirements including FDA, EU, and TGA Regulations and Saluda’s Quality Management System.
- Participate and support internal and external audits of Saluda MN site processes and compliance with established procedures.
Essential Requirements:
- 5 years of experience in the medical device industry or other regulated industry.
- Demonstrated strong attention to detail.
- Effective verbal and written communication skills in working with varying levels and functions of an organization.
- Ability to work on-site at Saluda Minnesota site (Bloomington) 5 days a week.
Desirable Requirements:
- An understanding of the requirements of ISO 13485 and 21CFR 820
- LEAN manufacturing training
- Experience in Product Microbial Testing.
Saluda Medical embraces diversity and equal opportunity. We are committed to building a team representative of a variety of backgrounds, perspectives and skills. We believe people are the source of our inspiration and innovation.
