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Senior Manager, Quality Engineering (2nd Shift)

Edwards Lifesciences

Philadelphia, PA

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JOB DETAILS
SKILLS
Analysis Skills, Best Practices, Budgeting, Calendar Management, Coaching, Communication Skills, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Support/Service, Detail Oriented, Documentation, Employee Relations, Employee Terminations, Environmental Health, Experiment Design, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Healthcare Providers, ISO (International Organization for Standardization), Interpersonal Skills, Leadership, Lean Manufacturing, Lean Six Sigma, Manufacturing Methods, Manufacturing/Industrial Processes, Medical Equipment, Metrics, Microsoft Office, Negotiation Skills, Organizational Development/Management, Patient Care, Pollution Prevention, Problem Solving Skills, Process Capability, Process Failure Mode and Effects Analysis (PFMEA), Product Design, Product Development, Production Management, Project Planning, Project/Program Management, Quality Engineering, Quality Management, Regulatory Compliance, Regulatory Requirements, Relationship Management, Resolve Customer Issues, Risk Analysis, Risk Management, Safety Standards, Safety/Work Safety, Sales Management, Schedule Development, Statistical Process Control, Strategic Planning, Talent Management, Team Lead/Manager, Technical Leadership, Technical/Engineering Design, Vaccination
LOCATION
Philadelphia, PA
POSTED
30+ days ago
This role is required to be onsite. Selected candidate must reside within a reasonable commuting distance to Edwards campus in Draper, Utah. We are also willing to provide relocation assistance for candidates willing to move to the Salt Lake City metro area.


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 Sr. Manager, Quality Engineering 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.


How You'll Make an Impact:


+ Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design on new products and/or processes. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups

+ Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department

+ Provide technical guidance to cross-functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity

+ Lead the implementation of CAPA program including training, approvals, and system effectiveness

+ Other incidental duties


What You'll Need (Required):


+ Bachelor's Degree in related field, related experience in engineering or equivalent work experience based on Edwards criteria Required and

+ Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry or equivalent work experience based on Edwards criteria Required and

+ Demonstrated track record in management of technical and/or engineering disciplines or equivalent work experience based on Edwards criteria Required


What Else We Look For (Preferred):


+ Experience working in a regulated industry or equivalent work experience based on Edwards criteria Preferred

+ Proven successful project management leadership 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

+ Expert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines

+ Expert understanding of related aspects of quality engineering processes and/or systems

+ Expert 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

+ Knowledge of financial acumen as it relates to the business as well as quality engineering

+ Demonstrated ability to direct teams 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 engineering to the business

+ Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT

+ 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

+ Frequently interacts with subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team

+ Participate and present at meetings with internal and external representatives

+ Resolve operational and scheduling issues

+ 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.

+ Develop relationships and leverage them to influence change

+ Support and solicit input from team members at all levels within the organization

+ 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


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.

About the Company

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Edwards Lifesciences