Manager, Equipment Quality & Controls

TransMedics, Inc.•Andover, MA

10d•$139,450 - $173,950

About The Position

The Manager, Equipment Quality & Controls will be responsible for building and leading a robust, scalable, and compliant equipment controls program across all manufacturing sites. This leader will transform the current paper-based processes into fully digital workflows within our MES (Critical Manufacturing) system, driving standardization, efficiency, and a quality mindset across the equipment lifecycle. This role will own global process design, deployment, governance, and continuous improvement for equipment qualification, calibration, preventive maintenance, change control, and associated system controls for all manufacturing equipment. As the company expands to new sites, this position will serve as the primary architect and implementation lead, ensuring a harmonized, audit-ready program.

Requirements

Bachelor’s degree in Engineering, Quality, or related technical field.
7+ years of experience in a regulated medical device, pharmaceutical, or biotechnology manufacturing environment.

Nice To Haves

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.

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.