Remote Manager, Quality Compliance (Remote USA) en Edwards

This role may be based remote anywhere in the United States (must be flexible to work PST hours).

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.

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).

What you’ll need:

• Bachelor’s degree required, with proven experience in Quality Assurance or Quality Control within a regulated industry.

• Minimum of 5 years’ experience in commercial quality.

• Proven people leadership and project management experience.

What else we look for:

• Prior clinical experience in Medical Device Industry, Quality Systems, or hospital/clinical environment (e.g. cardiac care, ICU, OR, or cardiovascular/endovascular interventions) required. Combination of both big plus.

• Project Management Certification or experience.

• In-depth knowledge of Quality Management Systems and Processes.

• Proven expertise in both Microsoft Office Suite and related systems.

For California, the base pay range for this position is $118,000 to $167,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. 

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.