Manager, Quality Control at TransMedics

Compensation

$118,600 – $148,000/yr

Location: Somerville, Massachusetts
Type: Full-time

Description

The Manager, Quality Control position at TransMedics involves ensuring product compliance with internal and external standards, safety regulations, and customer expectations. Key responsibilities include overseeing quality control activities, managing and mentoring staff, analyzing data, and mitigating defects. The role supports manufacturing operations, participates in continuous process improvement, and ensures adherence to regulatory frameworks like 21 CFR 820, ISO 13485, MDSAP, and MDR.

Required Skills

Quality Control
Management
FDA QSR
ISO 13485
Statistical Techniques
Microsoft Office Suite

Additional Information

Minimum Education: BS in Engineering or Life Sciences or equivalent combination of education and experience
Required Previous Experiences: At least 5 years’ experience in managing direct reports in a Quality Control function
Manufacturing and sterilization (including cleanroom) experience
Preferred Qualifications: Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations. Experience with MDR a plus.
Knowledge of statistical techniques.
Proficient in MS Office Suite (i.e. Word, Excel, PowerPoint, Access).
Must be team-oriented and collaborative
Excellent interpersonal skills demonstrating the ability to work with others in a professional positive and collaborative manner
Ability to work in a fast-paced environment and to meet tight deadlines
Willingness to learn, possess a can-do attitude, and motivated to succeed and grow
Ability to multi-task with strong attention to detail
Proven Ability to provide logical, in-depth analysis of a problem or situation

About TransMedics

TransMedics

medical devicesAndover, MA501-1000

TransMedics provides end-to-end technology & expert clinical service solutions that maximize heart & lung transplant volume, clinical outcomes and reduce learning curves.

Open roles: 33
Founded: 1998

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