Senior Quality Systems Engineer

MINIMUM QUALIFICATIONS

• Bachelor’s Degree in Engineering, Biomedical Science, or other technical discipline preferred, with 5-7 years of relevant experience in medical device industry, including responsibility for Product Quality and/or Quality Systems
• A working knowledge of Quality System Standards and regulations, including 21 CFR Part 820, ISO 13485, EU MDR
• Ability to multi-task, handling multiple projects and changing priorities
• Experience in the creation and documentation of procedures and processes
• Must be results-driven and exhibit a sense of urgency
• Proficiency with Microsoft Office - Word, Excel, PowerPoint and Access experience required

• Supports the overall QMS processes for the organization. Responsible for activities required to ensure compliance of Quality Management Systems (QMS), specifically regarding CAPA and internal/external audits. Additional responsibilities include supporting other QMS functions such as NCMRs, Supplier Controls, Management Review, Risk Review, etc.
• Execution and coordination of activities associated with CAPA program, including administration and record management, providing quality input to investigations, reporting, as well as metrics and trending
• Support CAPA Owners in quality-related technical principles, including but not limited to Problem Solving tools and techniques (Root Cause Analysis, DOE, FMEA, etc.)
• Manages the Internal Audit program, including scheduling audits, ensuring timely response to findings, as well as metrics and trending
• Support external audits and inspections by providing subject matter expertise
• Development of Quality Metrics, and coordination of quality data collection and analyses for use in monthly metrics meetings and Management Reviews
• Provide quality assurance support cross-functionally across the organization
• Lead/participate in Risk Management and FMEA initiatives
• Develop, implement, and manage Quality Control/Quality System process improvements.
• Identify opportunities for improvement within the Quality System to ensure compliance and efficiency. Correct or improve gaps/opportunities in an independent fashion by writing and releasing new or revised Quality System documentation
• Understand how and when to escalate quality issues to leadership team within the organization, presenting data and information necessary to draw conclusions and take action
• Provide training and support to employees on quality processes and procedures
• Support work on quality plans, quality processes and special projects, as required
• Perform other TransMedics tasks and duties as assigned/required