Quality Assurance Manager, NPD, Endotronix

Edwards Lifesciences is growing and our

Quality Assurance Manager, NPD, Endotronix

position is a unique career opportunity that could be your next step towards an exciting future. This role will sit within the Endotronix team, who develop implantable heart monitoring technology. Endotronix was acquired by Edwards in July 2024, and will support our future work with heart failure management solutions to address large unmet structural heart patient needs and support sustainable long-term growth.

For more details on the acquisition, please visit:

https://www.edwards.com/newsroom/news/2024-07-24-edwards-lifesciences-expands-structural-heart-port

How you will make an impact:

Manage a team with activities that focus on implementing and optimizing quality engineering practices while ensuring a culture of quality and compliance with global regulatory requirements.

Key Responsibilities:

Manage and/or lead a small team within assigned function. Develop team members to increase business acumen and functional skills

Work on complex issues where analysis of issues requires in-depth knowledge

Plan and direct assigned operational and project activities with the accountability for successful completion of assigned deliverables

Identify opportunities and lead the implementation of changes to drive improvements

Oversee engineering tasks; provide technical guidance and feedback to technicians/engineers; Guide lower level employees on more complex procedures

Create/update complex engineering documents including requirement specs, and risk documents with robust knowledge on design control requirements

Collaborate with cross-functional teams to lead the implementation of CAPA program including training, approvals, and system effectiveness

Other incidental duties

What you'll need (Required):

Bachelor's Degree in in related field related experience in engineering Required and

Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry Required

Experience working in a regulated industry Preferred

What else we look for (Preferred):

Additional Skills:

Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills

Proven successful project management skills

Proven expertise in both Microsoft Office Suite and related systems

Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making

Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

Extensive understanding of engineering procedures while defining team operating standards

Extensive understanding of related aspects of quality engineering processes and/or systems

Extensive knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards)

Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing

Basic financial acumen as it relates to quality engineering

Demonstrated skill set to manage small team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations

Ability to influence cross-functional partners

Ability to integrate metrics into the projects and operations

Strict attention to detail

Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

Ability to work and excel within a fast paced, dynamic, and constantly changing work environment

Primarily interacts with internal subordinates and other supervisors

Typically interacts with external suppliers, vendors and/or customers

Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules

Dedicated to quality client service and pro-active and responsive to client needs.

Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.

Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For Illinois (IL) , 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.