The Senior Manager, R&D Device Quality will support the development of medical devices and/or device components of combination products by providing directions on applicable design control, human factors/usability engineering, and risk management processes. This position will engage with all areas involved in the product development process and provide direction and consultation assuring the design control system is effectively established, executed, and maintained. This position will participate in product risk assessment efforts, including hazard analysis and design failure mode effect analysis, and development of the risk management plans.
Responsibilities:
- Provides quality system methodology guidance, support and review for medical device products throughout the design and development and change control processes.
- Actively participates in cross-functional design teams assessing design documentation for quality characteristics, including product requirements, safety risk management, design verification, design validation, manufacturability, serviceability, biocompatibility, sterilization, packaging and reliability.
- Works with product development engineering and manufacturing engineering to translate design requirements into manufacturing requirements to achieve design for manufacturability.
- Serves as a technical resource for problem investigations to guide root cause analysis / corrective action development.
- Facilitates and leads design and reliability activities related to Design, Manufacturability, and Reliability (DRM) practices. This includes planning, leading, facilitating, and supporting activities such as robust engineering, reliability predictions, capability analysis, development of CTQ's, VOC, requirements flow down, etc.
- Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485 Regulations, and other applicable standards.
- Provide quality oversight for clinical batch manufacturing, including equipment qualification, adherence to approved processes, data traceability, and clinical batch release.
- Develop and implement site QA strategies, improve design control and risk management processes, support a consistent and compliant MDCP quality management system, oversee Operations QA activities, and contribute to CAPA investigations and resolution.
- Support regulatory audits and inspections as subject matter expert, while driving quality harmonization, data-informed improvements, and initiatives that enhance process effectiveness and product performance.
- Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals and Medical Devices worldwide.
- Supports changes to quality standards to ensure conformance and continuous improvement.