Quality Assurance Engineering Manager

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.  In this role, you will manage a team to ensure smooth and continuous operations in quality.  In this role, you will 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.

How you will make an impact: 
• 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
• 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
• Plan and direct assigned operational and project activities with the accountability for successful completion of assigned deliverables.
• Manage a small team within area and develop team members to increase business acumen and functional skills
• Identify opportunities and lead the implementation of changes to drive improvements
• Other incidental duties

What you'll need (Required):
• Bachelor's degree in related field , 6 years demonstrated experience with people management 
• Demonstrated technical expertise within assigned quality area 
• Master's Degree or equivalent in related field, 5 years demonstrated experience with people management 

What else we look for (Preferred):
• Experience working in a regulated industry 
•  ASQ CQE is preferred 
•  Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills
• Proven successful project management leadership skills
• Proven expertise in Microsoft Office Suite; experience in related quality systems preferred
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Extensive understanding of quality procedures while defining team operating standards and ensuring essential procedures are followed based on knowledge of own area
• Extensive understanding of related aspects of quality processes and/or systems
• Extensive knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards)
• Knowledge of financial mechanism that relates to area
• Demonstrated skill set to manage assigned 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 develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality to the business
• Knowledge and adherence to applicable regulatory requirements (e.g., ISO 13485, QSR)
• 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.