Senior Director, Quality Assurance

• Please note that this is an "onsite" role based in Draper, Utah. Hence, the successful candidate will be expected to work from our Draper, Utah facility.
  
  

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 Senior Director, Quality Assurance 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 Qualifications):

• Bachelor's or Master’s degree with at least 10 years of experience within quality assurance, quality engineering, and/or manufacturing operations.
• Experience in managing internal audit programs and inspections/audits by external regulatory agencies for class II/III medical devices
• Demonstrated track record in people management
  
  

What else we look for (Preferred Qualifications):

• Experience working in a regulated industry, preferably the medical device or pharmaceutical industry
• Experience in engineering or technical background.
• Experience in supporting/implementing FDA’s Case for Quality program
• In-depth understanding of quality procedures while identifying applications of functional knowledge and existing methodologies to complex problems
• Deep knowledge and understanding of related aspects of quality processes, systems, and regulations (e.g., cGMP compliance)
• Proven successful project management leadership skills
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality to the business
• Proven expertise in both Microsoft Office Suite, including advanced Excel and related systems
• Knowledge of Lean Manufacturing concepts and Six Sigma
• 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
  
  

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.