- Envista Holdings Corporation (Quakertown, PA)
- …a growing, energetic, and diverse mix of professionals spanning engineering, operations , regulatory and quality backgrounds that work collaboratively in the ... professional relationships across the organization. **POSITION SUMMARY** The **Quality Assurance Manager ** (QA Manager ) is responsible for leading the Quality… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Director will build and lead a high-performing team to ensure global operations meet or exceed standards, aligning with regulatory requirements and business goals. ... standards such as 21 CFR 820.198 (Complaint Handling) and 21 CFR 803.3 ( MDR Reporting), aligning with company goals. + Leadership and Team Development: Build strong… more
- West Pharmaceutical Services (Exton, PA)
- …support submissions including Premarket Notifications, Technical Documentations under EU MDR (Medical Device Regulation), and Master Files (DMF/MAF) associated with ... state-of-art standards/regulations. + Collaborate with regulatory lead(s), cross-functional project manager (s) and SMEs (Subject Matter Experts) in R&D, quality… more