Baxter is looking to solve problems related to product development, quality processes, and regulatory compliance within the healthcare industry by hiring a Principal Quality Engineer.
Requirements
- Proficient in relevant products or process development processes (i.e. NPD and sustaining-life cycle management)
- Must have experience with crafting/managing Design History File (DHF) and Risk Management File (RMF)
- Solid understanding of FDA Regulations (e.g. 21 CFR Part 820), Application of Good Laboratory Practices, Application of Good Manufacturing Practices, ISO (e.g. ISO13485 and ISO14971) and other applicable standards (e.g. IEC60601 and IEC62304 electromechanical medical device) and ISO 22442 (Med Devices using animal tissues) and regulatory requirements (e.g., EU MDD and MDR)
Responsibilities
- Applies innovative techniques in the area of expertise to develop new or improved products and processes
- Independently plans, schedules and leads cross-functional team in detailed phases of the Quality work in a project
- Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvement
- Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements
- Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
- Take lead role in NCR/CAPA activities such as investigation, implementation, or verification of effectiveness
- Provide product quality support on new product development, risk management, design transfer and sustaining engineering core team
Other
- Minimum of 6 years’ experience in Quality, Manufacturing, Engineering or related field
- Demonstrated success in delivering results on several technical/product/Quality challenges
- ASQ and/or Six Sigma Blackbelt Certification preferred
- Product development experience with medical devices preferred
- Demonstrates leadership skills to handle sustaining product support activities involving Complaint investigations, Trigger evaluations and Change controls
