About the role
About Pirouette Pharma
Pirouette's mission is to make self‑care with injectable medications simple, comfortable, and reliable—so patients can manage chronic conditions at home with confidence and fewer barriers.
Position Summary
The Manufacturing Line Quality Engineer will provide day to day quality support for production lines that manufacture combination products. This role is primarily floor-facing and ensures that materials, in process activities, equipment, and final products meet Pirouette Pharma’s standards for safety, quality, and compliance. The ideal candidate is detail oriented, proactive, and thrives in a dynamic manufacturing environment.
Key Responsibilities
Floor Support & Quality Oversight
- Provide on-the-floor quality engineering support to manufacturing operations for combination products.
- Perform and document line clearances prior to batch start, product changeovers, and as required throughout production.
- Ensure labeling control requirements are met.
Incoming & In‑Process Quality Control
- Conduct incoming inspection of components and materials (visual, dimensional, and functional tests as applicable).
- Support in‑process quality checks to ensure compliance with approved procedures and specifications.
Final Device Testing
- Execute and document final device testing per established test methods and quality standards.
- Troubleshoot and escalate any issues identified during testing.
Documentation & Batch Record Review
- Perform batch record reviews (BRR) for completeness, accuracy, and GMP compliance.
