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# Senior Quality Systems Engineer

- **Company:** Transmedics Inc
- **Location:** Andover, MA, United States
- **Experience:** Expert
- **Contract:** Temporary contract
- **Skills:** Microsoft Access, Microsoft Word, Microsoft Excel, Data Presentation, Failure Mode Effects Analysis, Microsoft PowerPoint
- **Published:** October 28, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=1976099d73859792

## About the Role

* 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, * Experience participating in internal and external audits, preferably serving as qualified internal auditor
 * Ability to communicate ideas and information clearly, effectively, and frequently (both oral and written)
 * Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results
 * Ability to act independently to determine methods and procedures
 * Problem-solving skills and the ability to resolve issues as they arise
 * Strong interpersonal skills, with the ability to assimilate with various cross-functional teams

## Description

We are seeking a dynamic, analytical thinking individual to join our Quality team, focusing on Quality Systems, CAPA, Internal Audit, metric reporting and process improvement initiatives. The ideal candidate will possess a strong background in medical devices or IVD, with a proven track record in managing quality-related activities in a fast-paced dynamic environment. QMS experience is essential. This is a four month position to fill in while another employee is on leave., This position is responsible for, but not limited to, the following:

 * 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
*