TransMedics, Inc. · 3 days ago
Senior Quality Systems Engineer
Andover, MA
Full-time
Onsite
Senior Level
5+ years expTransMedics, Inc. is seeking a dynamic, analytical thinking individual to join their Quality team as a Senior Quality Systems Engineer. This role focuses on Quality Systems, CAPA, Internal Audit, metric reporting, and process improvement initiatives in the medical device industry.
Health CareMedicalMedical DeviceService IndustryWellness
Responsibilities
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
Qualification
Required
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
Must be able to lift 50lbs
Preferred
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
Company
TransMedics, Inc.
Every Organ Wasted is a Life Not Saved. TransMedics, Inc.
Founded in 1998Andover, Massachusetts, USA
501-1000 employees
H1B Sponsorship
TransMedics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (4)
2023 (3)
2022 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$721.33MKey Investors
CIBC Innovation BankingAbrams CapitalTudor Investments
2023-05-08Post Ipo Debt· $400M
2022-09-15Post Ipo Debt· $60M
2020-04-24Post Ipo Debt· $2.2M
Leadership Team
Waleed Hassanein
President & CEO
Gerardo Hernandez
Chief Financial Officer
Recent News
thefly.com
2025-11-19
2025-11-01
2025-10-31
Company data provided by crunchbase