Quality Engineering Manager; 2nd Shift

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Quality Engineering Manager (2nd Shift) position is a unique career opportunity that could be your next step towards an exciting future.

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

Manage 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'll 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

• 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 engineering or related field, with experience in Quality Engineering, Quality Management, or Regulatory Compliance within the medical device industry; prior work in regulated industries preferred.

What Else We Look For (Preferred):

• 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…