Manager, Quality Compliance (Remote USA) at Edwards Lifesciences
Irvine, California, USA -
Full Time


Start Date

Immediate

Expiry Date

10 Oct, 25

Salary

167000.0

Posted On

10 Jul, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

It

Industry

Pharmaceuticals

Description

HOW YOU’LL MAKE AN IMPACT:

  • Leading a Quality Compliance team to ensure that complaint handling and vigilance reporting processes are executed in strict alignment with internal procedures and global regulatory requirements.
  • Overseeing team performance, developing staff capabilities, and ensuring that all activities meet compliance standards.
  • Serving as the process owner for quality compliance systems, generate and analyze metrics to identify improvement opportunities, and lead projects from initiation to completion.
  • Staying current with regulations and driving continuous improvement initiatives are key aspects of the role.
  • Collaborating across functions to enhance training programs, improve user experience, and ensure the integrity of compliance systems.
  • Interacting with internal teams and external stakeholders and having a proactive approach to client service, regulatory adherence, and environmental and safety protocols.
  • Traveling up to 20% may include daytime, overnight, car and air travel).
Responsibilities

Imagine how your ideas and expertise can change a patient’s life.
Our Global Supply Chain (GSC) Quality Compliance team plays a critical role in ensuring that every product complaint is addressed with the highest standards of accuracy, integrity, and regulatory compliance. Working at the intersection of engineering, product safety, imaging, and clinical teams, we ensure that all complaints are thoroughly investigated and resolved in accordance with FDA regulations. This collaborative approach not only strengthens our compliance posture but also drives continuous improvement in product quality and patient outcomes. Whether your work involves complaint handling, root cause analysis, or cross-functional collaboration to enhance product safety, you are making a meaningful contribution to delivering the best possible products to patients with cardiovascular disease around the world.

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