The Quality Systems Engineer will provide quality systems expertise in support of Quality Systems and Processes including Corrective and Preventive Action (CAPA), Complaint Handling, Management Review, Quality metric reporting, and Internal/External Audits.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Know and follow local and global policies and procedures.
- Provide quality systems guidance and support to the Corrective and Preventive Action (CAPA) process as a Subject Matter Expert (SME).
- Collaborate with representatives from other functional areas to facilitate timely and effective Corrective and Preventive Action (CAPA) investigations, action plan implementation, and effective monitoring.
- Provide quality systems guidance and support to the Complaint Handling process as a Subject Matter Expert (SME).
- Collaborate with representatives from other functional areas to facilitate timely and accurate Manufacturing Investigations and Device History Reviews.
- Own and lead the metrics data collection and Management Review process.
- Monitor, analyze, and report Quality Management System metrics relating to the CAPA and Complaint Handling systems.
- Lead readiness activities and provide back room support for internal/external audits and inspections.
- Identify opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives.
- Support and participate in cross-functional and multi-site projects, facilitate technical innovations to enhance Quality Systems, and assist with other Quality Systems activities as requested by management.
- The Quality Systems Engineer will support both the Brandywine and Wilson Drive Manufacturing sites.
- Support document control and change management activities.
- Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies and procedures, for new assignments and for implementation of new policies and procedures.
- Follow local and global safety policies and procedures and participate in safety initiatives.
EDUCATION & EXPERIENCE REQUIREMENTS
- Bachelor’s degree in engineering or science preferred; and one to two years experience; or equivalent combination of education and experience.
- Experience in medical device or pharmaceutical industry preferred.