Director, Quality Systems - Edwards Lifesciences
Salt Lake City, UT
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.
The Director, Quality Systems will manage a team to ensure smooth and continuous operations of our site quality system, quality control and assurance inspection for in process and finished goods. They will also oversee process audits and final product release documentation, advise and facilitate failure investigations, and share compliance methodologies for manufacturing of valve assemblies.
How you’ll make an impact:
+ Manage supervisors, managers, and/or experienced professionals and activities including quality control, exception handling, process audits to achieve release and compliance expectations. Drive quality culture and engage staff morale. Develop a robust talent development plan in alignment with functional growth strategies of the department.
+ Plan and direct multiple complex quality assurance projects (e.g., CAPA) with the accountability for successful completion of all project deliverables to the business within established schedule, scope, and quality objectives. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups • Negotiate solutions and reaching consensus with cross-functional groups to drive business line continuity and/or continuous improvement of quality assurance areas
+ Responsible for inspection of in-process and finished goods, assemblies and components including proper implementation
+ Interface with cross-functional teams (e.g., Manufacturing Operations, Supply Chain, and Engineering) to ensure tactical execution of business objectives
+ Provide recommendations and implement workforce planning
+ Lead efforts to optimize business processes and systems by assessing business needs and developing, proposing and implementing technology solution options.
+ Act as a Subject Matter Expert (SME) in business processes in the area of responsibility. Define effective and efficient business process workflow, including process modifications in partnership with stakeholders
+ Other incidental duties
What you’ll need (Required):
+ Bachelor's Degree in a related field Required
+ Experience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices Required
+ Demonstrated track record in people management Required
What else we look for (Preferred):
+ Experience working in a regulated industry, preferably the medical device or pharmaceutical industry
+ Experience in supporting/implementing FDA’s Case for Quality program
+ Proven successful project management leadership skills
+ Proven expertise in both Microsoft Office Suite, including advanced Excel and related systems
+ 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 quality procedures while identifying applications of functional knowledge and existing methodologies to complex problems
+ Expert understanding of related aspects of quality processes and/or systems
+ Expert knowledge of financial acumen as it relates to quality
+ Expert knowledge of applicable quality regulations (e.g., cGMP compliance)
+ Demonstrated ability to manage one or more 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 to the business
+ 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
+ Knowledge of Lean Manufacturing concepts and Six Sigma
+ Frequently interacts with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
+ Lead briefings and technical meetings for internal and external representatives
+ Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
+ 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.
+ Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
+ Develop relationships and leverage them to influence change
+ Support and solicit input from team members at all levels
+ 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.
The Director, Quality Systems will manage a team to ensure smooth and continuous operations of our site quality system, quality control and assurance inspection for in process and finished goods. They will also oversee process audits and final product release documentation, advise and facilitate failure investigations, and share compliance methodologies for manufacturing of valve assemblies.
How you’ll make an impact:
+ Manage supervisors, managers, and/or experienced professionals and activities including quality control, exception handling, process audits to achieve release and compliance expectations. Drive quality culture and engage staff morale. Develop a robust talent development plan in alignment with functional growth strategies of the department.
+ Plan and direct multiple complex quality assurance projects (e.g., CAPA) with the accountability for successful completion of all project deliverables to the business within established schedule, scope, and quality objectives. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups • Negotiate solutions and reaching consensus with cross-functional groups to drive business line continuity and/or continuous improvement of quality assurance areas
+ Responsible for inspection of in-process and finished goods, assemblies and components including proper implementation
+ Interface with cross-functional teams (e.g., Manufacturing Operations, Supply Chain, and Engineering) to ensure tactical execution of business objectives
+ Provide recommendations and implement workforce planning
+ Lead efforts to optimize business processes and systems by assessing business needs and developing, proposing and implementing technology solution options.
+ Act as a Subject Matter Expert (SME) in business processes in the area of responsibility. Define effective and efficient business process workflow, including process modifications in partnership with stakeholders
+ Other incidental duties
What you’ll need (Required):
+ Bachelor's Degree in a related field Required
+ Experience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices Required
+ Demonstrated track record in people management Required
What else we look for (Preferred):
+ Experience working in a regulated industry, preferably the medical device or pharmaceutical industry
+ Experience in supporting/implementing FDA’s Case for Quality program
+ Proven successful project management leadership skills
+ Proven expertise in both Microsoft Office Suite, including advanced Excel and related systems
+ 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 quality procedures while identifying applications of functional knowledge and existing methodologies to complex problems
+ Expert understanding of related aspects of quality processes and/or systems
+ Expert knowledge of financial acumen as it relates to quality
+ Expert knowledge of applicable quality regulations (e.g., cGMP compliance)
+ Demonstrated ability to manage one or more 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 to the business
+ 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
+ Knowledge of Lean Manufacturing concepts and Six Sigma
+ Frequently interacts with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
+ Lead briefings and technical meetings for internal and external representatives
+ Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
+ 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.
+ Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
+ Develop relationships and leverage them to influence change
+ Support and solicit input from team members at all levels
+ 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.
Source : Edwards Lifesciences
