We are currently looking for a Project Manager for our client's in Atlanta, GA.
- Manage RMI and CM projects by interfacing and coordinating between customers, purchasing, materials, production, quality, regulatory, and engineering.
- Write technical reports and documentation (i.e., Design History, Risk Management, Product Realization Files, Mold Verifications and Product/Process Validations).
- Update and maintain engineering drawings and documentation.
- Interface with customers and suppliers externally and multiple disciplines internally.
- Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), ISO, and FDA requirements.
- BS degree in Engineering (or related discipline) or education/experience equivalency preferred.
- 6+ years of related project management experience preferably in medical device or other FDA regulated industry.
- Strong knowledge of product life cycle processes/protocols, injection molding products/equipment/processes, electrical systems, mechanical and hydraulic application, and lean manufacturing.