Senior Manager, Quality Engineering - Edwards Lifesciences
Irvine, CA
About the Job
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.
In this role, you will manage a team with activities that focus on implementing and optimizing quality engineering practices related to Complaints Evaluation, Post Market Surveillance and Risk Management while ensuring a culture of quality and compliance with global regulatory requirements.
How you will make an impact:
• Manage 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 (Root Cause, Investigation, Data Analysis), 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 team of Engineers 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 complaints evaluation with cross functional team
• Deliver Post Market Surveillance for commercially released products for the Business Unit
• Drive Risk Management activities for products
• Implementation of CA/PA and continuous improvement programs
• Other incidental duties
What you'll need (Required):
• Bachelor's Degree in in Science, Technology or Engineering
• 10+ Years of experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry
• Demonstrated experience in management of technical and/or engineering disciplines
What else we look for (Preferred):
• Experience working in a regulated industry
• 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
• Good 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
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 California, the base pay range for this position is $133,000 to $187,000 (highly experienced).
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.
In this role, you will manage a team with activities that focus on implementing and optimizing quality engineering practices related to Complaints Evaluation, Post Market Surveillance and Risk Management while ensuring a culture of quality and compliance with global regulatory requirements.
How you will make an impact:
• Manage 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 (Root Cause, Investigation, Data Analysis), 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 team of Engineers 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 complaints evaluation with cross functional team
• Deliver Post Market Surveillance for commercially released products for the Business Unit
• Drive Risk Management activities for products
• Implementation of CA/PA and continuous improvement programs
• Other incidental duties
What you'll need (Required):
• Bachelor's Degree in in Science, Technology or Engineering
• 10+ Years of experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry
• Demonstrated experience in management of technical and/or engineering disciplines
What else we look for (Preferred):
• Experience working in a regulated industry
• 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
• Good 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
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 California, the base pay range for this position is $133,000 to $187,000 (highly experienced).
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.
Source : Edwards Lifesciences
