Operations Specialist
The Operations Specialist will support the day-to-day manufacturing and operational activities of our medical device production team. This role plays a critical part in ensuring efficient production workflows, accurate documentation, and compliance with industry regulations. The ideal candidate is highly organized, quality-focused, and eager to contribute to a fast-paced, regulated manufacturing environment.
Essential Responsibilities :
- Assist in process improvement initiatives to enhance efficiency, reduce waste, and maintain compliance.
- Maintain and update ERP system data, ensuring accuracy and timeliness of information.
- Support daily manufacturing operations by coordinating production schedules, tracking work orders, and ensuring timely material availability.
- Assist in preparing, reviewing, and organizing manufacturing & quality documentation, including batch records, travelers, and device history records (DHRs).
- Track, compile, and report on operational metrics and KPIs to support data-driven decision-making.
- Assist in preparing financial analyses, cost breakdowns, and budget tracking reports.
- Collaborate with cross-functional teams including Production, Quality, Engineering, Supply Chain, and Finance teams to ensure smooth operations.
- Assist in preparing presentations, dashboards, and reports for leadership review.
Job Requirements Qualifications & Skills :
Associate's or Bachelor's degree in Business, Operations, Engineering, or related field (or equivalent experience).Previous experience in manufacturing, preferably in the medical device or other regulated industry.Proficiency with Microsoft Excel; experience with ERP / MRP systems preferred.Strong organizational skills and attention to detail.Ability to work collaboratively across departments and communicate effectively.Knowledge of GMP, ISO 13485, and FDA quality system requirements a plus.This role is an in-office position at Stereotaxis' Rogers, MN site. Stereotaxis values steadfast integrity, intellectual excellence, responsiveness and reliability, and a dedication to constant improvement. We take pride in the positive impact of our work and in building a collaborative and innovative work environment that embraces challenge.