Manufacturing Line Quality Engineer

**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. * Ensure timely resolution of discrepancies or data integrity concerns. **Nonconformance & Investigation Support** * Initiate, support, and document nonconformance reports and associated investigations. * Quarantine nonconforming materials as required. * May assist root cause analysis and implementation of corrective/preventive actions (CAPA). **Calibration & Equipment Quality Checks** * May administer calibration program and ensure timely calibration of Pirouette equipment either in-house or via approved vendors. * Perform periodic calibration of designated gauges, fixtures, and test equipment. * Maintain accurate calibration documentation and support equipment related quality investigations. **Compliance & Continuous Improvement** * Ensure that all work adheres to applicable cGMP, ISO, and FDA regulatory requirements for combination products. * Participate in continuous improvement initiatives to enhance product quality and operational efficiency. **Additional Responsibilities** * Support audits, change controls, validation activities, and cross functional quality initiatives as needed. * Perform other duties as assigned by leadership. --- **Qualifications** **Required** * Bachelor’s degree in Engineering, Life Sciences, or a related technical field — or equivalent practical experience. * 2-4 years prior experience in a regulated manufacturing environment (pharma, medical device, or combination products preferred). * Strong attention to detail, organizational skills, and documentation accuracy. * Ability to work effectively on the production floor in a fast-paced environment. * Basic understanding of quality systems, cGMP, and data integrity principles. **Preferred** * Experience with combination product manufacturing, device assembly lines and/or cleanroom experience. * Familiarity with root-cause analysis tools (5 Whys, Fishbone, etc.). * Familiarity with Lean manufacturing principles. * Hands‑on experience with inspection, measurement tools, or test equipment. * Knowledge of FDA 21 CFR Part 4, 210, 211 and 820, ISO 13485, or similar regulatory standards. --- **Working Conditions** * Frequent time spent in controlled manufacturing areas (cleanrooms, labs, and production lines). * Ability to stand, walk, and perform manual tasks for extended periods. * Some off-shift or weekend support may be required during investigations or production demands.