Manager, Combination Product Development

What You’ll Do Generate process, product, and life cycle metrics via statistical analysis Participate in Management Review for combination product quality metrics Review PQC monthly metrics Conduct risk assessment/analysis and maintain risk management file including annual review of UFMEA Perform technical assessments to update design history file for design/process changes Lead complaint trend investigations (combination product and/or device) Lead manufacturing investigations (combination product and/or device) Serve as point of contact for the device manufacturer; organize regular technical meetings Draft NDA amendments for major changes Own device change technical assessment and change control process Perform technical review of labeling, IFU, and training material changes Represent in CMC meetings to assess device/combination product impact Work effectively with cross-functional teams Experience in GxP systems Who You Are (Qualifications/Requirements) Bachelor’s degree + 5 years in engineering/operations Design Control and Risk Management experience CAPA lifecycle experience including root cause investigations (RCA techniques) Change Control experience Working knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485:2016, ISO 14971:2007, and EU Medical Device Regulation Excellent verbal and written communication Highly organized with strong attention to detail and clarity Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) Nice to Have (Preferred) Certified Quality Engineer (or similar) Statistical expertise (e.g., Minitab) Where You’ll Work / Travel / Pay Hybrid role (Bridgewater, NJ); remote most of the time Occasional global travel ~5%–10% $124,000.00–161,000.00 annual #J-18808-Ljbffr Scorpion Therapeutics