Quality Site Lead-(Mirandola, Italy)

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Job Overview

The Quality Site Lead position at TransMedics, Inc. represents an essential role in establishing and managing the Quality Management System (QMS) for a brand new R&D disposables and pilot manufacturing site located in Mirandola, Italy. This pivotal position involves ensuring that all activities adhere to global QMS standards, as well as regulatory requirements, while aligning with business objectives. The candidate will act as the primary liaison between corporate quality leadership and site operations.

Responsibilities

Quality System Implementation & Oversight

A core responsibility will be leading the deployment of TransMedics’ established QMS at the site, which includes the following key tasks:

• Ensuring compliance with FDA 21 CFR 820 and ISO 13485 standards.
• Translating corporate quality policies into actionable site-level processes, documentation, and training.
• Developing and maintaining specific quality procedures covering areas such as incoming inspection, manufacturing quality controls, calibration, and CAPA (Corrective and Preventive Actions).
• Actings as a quality reference for the site’s R&D team, coordinating between the R&D and Quality teams headquartered in Andover, MA, USA.

Site Readiness & Launch Execution

In preparation for the site’s launch, the Quality Site Lead will:

• Serve as the quality lead during all startup activities, including facility qualification and equipment installation.
• Collaborate with various teams (Engineering, Manufacturing, Operations) to ensure quality requirements are integrated into site setups.
• Drive the implementation of material inspection systems, in-process controls, and final release protocols to guarantee quality standards are met and sustained.

Operational Quality Leadership

As the site’s leading quality authority, the candidate will:

• Provide guidance on handling nonconformances and corrective actions.
• Conduct internal audits regularly and assist with external inspections as needed.
• Monitor site quality performance metrics and lead continuous improvement initiatives.

Collaboration & Communication

Effective collaboration will be vital, as the Quality Site Lead must:

• Work closely with corporate quality, regulatory, and operations teams to maintain compliance.
• Train and mentor site personnel, enhancing their understanding of quality requirements.
• Communicate site progress, risks, and milestones to leadership.

Qualifications

Minimum Qualifications

Candidates must possess the following qualifications:

• A Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 7+ years of experience in Quality Assurance or Quality Systems in the medical device or regulated life sciences sector.

Preferred Qualifications

While not mandatory, the following qualifications are preferred:

• Experience with new site setups, design transfer, or manufacturing scale-up processes.
• Proficiency in relevant regulations such as FDA 21 CFR 820, ISO 13485, and ISO 14971.
• A certification from ASQ (CQE, CQA, or equivalent) is highly desirable.
• Familiarity with ISO 9001, MDR, or MDSAP environments would be an asset.

Skills Required

The ideal candidate should demonstrate the following skills:

• Strong analytical abilities with a focus on continuous improvement.
• Exceptional communication, organization, and problem-solving skills.
• An effective balance of strategic planning and operational execution, vital in a dynamic startup environment.
• Proficiency with Microsoft Office tools to manage documentation and training processes effectively.

Working Conditions

• The job will be primarily conducted in an office environment with the capacity to occasionally travel (up to 10% of the time) across Europe and potentially to the US for training purposes.
• Physical attributes needed include the ability to lift up to 30 pounds unassisted.

Company Overview

TransMedics, Inc. is a pioneering medical technology company on a mission to enhance organ transplant therapies. Dedicated to improving patient care, TransMedics aims to facilitate increased access to viable donor organs, thus enhancing the quality of life for transplant recipients and their families. As part of their commitment to employee well-being, they offer a suite of benefits that includes medical, dental, vision, flexible spending accounts, and long-term disability options, as well as a 401K plan and an employee stock purchase plan.

Conclusion

The Quality Site Lead position at TransMedics, Inc. is a tremendous opportunity for candidates with substantial experience in Quality Assurance within regulated sectors. The position not only requires technical competence but also the ability to effectively manage quality operations in a fast-paced setting, making it ideal for individuals looking to make a significant impact in the realm of medical device manufacturing.

This job offer was originally published on himalayas.app