TransMedics, Inc. · 5 hours ago
Manager, Equipment Quality & Controls
Andover, MA
Full-time
Onsite
Mid, Senior Level
$139K/yr - $174K/yr
7+ years expTransMedics, Inc. is a commercial-stage medical technology company transforming organ transplant therapy for patients worldwide. The Manager, Equipment Quality & Controls will lead the development and implementation of a robust equipment controls program, ensuring compliance and efficiency across manufacturing sites.
Health CareMedicalMedical DeviceService IndustryWellness
Responsibilities
Develop and own the global Equipment Controls strategy, roadmap, and governance structure
Lead the transition from paper-based systems to fully digital, MES-integrated equipment controls (Critical Manufacturing)
Define and establish a scalable equipment management program that aligns with regulatory requirements (FDA QSR, ISO 13485, EU MDR) and internal quality policies
Design, implement, and maintain end-to-end equipment lifecycle processes, including:
Equipment specification, installation, qualification (IQ/OQ/PQ)
Calibration and preventive maintenance
Equipment status control, traceability, and risk classification
System access, change management, and documentation controls
Drive continuous improvement initiatives to enhance efficiency, compliance, and usability
Establish KPIs and dashboards to monitor program performance and equipment health
Partner with Manufacturing, IT, Engineering, and MES teams to build and deploy digital workflows for equipment processes
Serve as the Quality owner for equipment data integrity within the MES and other digital systems
Ensure global standardization of equipment master data, templates, and system configuration
Lead implementation of the equipment control program at new and existing manufacturing sites
Train and mentor site teams to ensure adoption and competency in the new digital processes
Act as SME during audits and inspections for equipment-related topics
Build and lead a small, scalable team responsible for equipment quality and controls across sites
Provide coaching, development, and mentoring to ensure high-quality execution and technical capability
Qualification
Required
Bachelor's degree in Engineering, Quality, or related technical field
7+ years of experience in a regulated medical device, pharmaceutical, or biotechnology manufacturing environment
Preferred
Proven experience with equipment qualification, calibration, maintenance programs, or equipment lifecycle controls
Demonstrated ability to build or enhance quality systems and digital workflows
Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and equipment control-related regulatory requirements
Experience working with MES systems; Critical Manufacturing experience strongly preferred
Excellent project management and cross-functional leadership skills
Experience leading multi-site or global quality programs
Prior experience building digital-first processes or migrating from paper to electronic systems
Supervisory or team leadership experience
Six Sigma or Lean certification a plus
Benefits
Medical with Health Reimbursement Account through Blue Cross/Blue Shield of MA
Dental
Vision
Healthcare Flexible Spending Account
Dependent Care Flexible Spending Account
Short Term Disability
Long Term Disability
401K Plan
Pet insurance
Employee Stock Purchase Plan
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
2026-01-22
Boston Globe
2026-01-19
FX News Group
2026-01-16
Company data provided by crunchbase