Manager, Quality Systems

Edwards Lifesciences • Irvine, CA

1d

About The Position

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 Manager, Quality Systemes position is a unique career opportunity that could be your next step towards an exciting future. The Manager, Quality Systems plays a critical role in improving and implementing processes within Quality Systems, including applications, documentation and training to strengthen our global Quality Systems infrastructure. This role will drive continuous improvement across core quality processes - including Change Control, Document Control, Records Retention, and Quality Training systems; while ensuring compliance, usability, and scalability. Working cross-functionally, this role partners with quality, digital transformation, and engineering teams to enhance system effectiveness, lead projects, and ensure users across the organization are enabled, trained, and compliant. How you will make an impact: Identify, lead and provide business process improvement solutions for Quality Systems, including reviewing and approving changes to procedures, to improve operation, efficiency, and user experience Owns the training program for Quality System related software including the quality training strategy, training content, curricula requirements and implementation oversight, partnering closely with stakeholders and training team globally. Lead moderately complex projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources, and representing quality management on cross-functional teams Manage all phases of the small to medium quality systems (e.g., CAPA, NCR,) Review and approve changes to documentation associated with Quality Systems, as well as assessing effectiveness and approving recommendations of others Drive investigations of basic problems, perform robust root cause analysis, develop and implement corrective actions, and establish monitoring plans in collaboration with cross functional SMEs Review and identify actions from metrics Prepare and pre-review data and documents for integrity prior to presentation in internal and external audit activities Provide technical directions to lower-level staff Other incidental duties assigned by Leadership Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

Requirements

• Bachelor’s degree with 8+ years of experience (or combined experience) within Quality, Quality Systems and/or Training; OR Master’s degree with 6+ years of experience (or combined experience) within Quality, Quality Systems and/or Training; OR equivalent work experience based on Edwards’ criteria
• Demonstrated experience working with Quality Systems (e.g. Change Controls, Document Controls, Records Retention, CAPAs, and/or Training)
• Medical Device or Pharma industry experience
• Ability to manage competing priorities in a fast-paced environment
• Ability to represent leadership on sections of projects within a specific area interfacing with project managers and quality systems team
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Excellent documentation, communication skills and interpersonal relationship skills including negotiating and relationship management skills

Nice To Haves

• Experience implementing, configuring, or administering Quality Management Systems (QMS) software such as ETQPLM platforms (e.g., Windchill PTC)
• Working knowledge of Product Lifecycle Management (PLM) processes within a regulated environment
• Working knowledge of Learning Management System (LMS) processes within a regulated environment
• Experience managing a training program for Quality Systems related software
• Experience with instructional design, training needs assessment, and training development. Creating and selecting effective learning materials including e-tools.
• Experience leading change management, project management, or program management initiatives
• Experience managing or supporting Learning Management Systems (LMS) and global training programs
• Background in business process improvement, including process mapping, metrics review, and system optimization
• Experience partnering with global stakeholders
• Extensive understanding of medical devices regulations (e.g., FDA (21 CFR Part 820), ISO13485, and ISO 14971)
• Background in training skills

Responsibilities

• Identify, lead and provide business process improvement solutions for Quality Systems, including reviewing and approving changes to procedures, to improve operation, efficiency, and user experience
• Owns the training program for Quality System related software including the quality training strategy, training content, curricula requirements and implementation oversight, partnering closely with stakeholders and training team globally.
• Lead moderately complex projects from inception through completion, including developing and/or scheduling key milestones, securing and allocating resources, and representing quality management on cross-functional teams
• Manage all phases of the small to medium quality systems (e.g., CAPA, NCR,)
• Review and approve changes to documentation associated with Quality Systems, as well as assessing effectiveness and approving recommendations of others
• Drive investigations of basic problems, perform robust root cause analysis, develop and implement corrective actions, and establish monitoring plans in collaboration with cross functional SMEs
• Review and identify actions from metrics
• Prepare and pre-review data and documents for integrity prior to presentation in internal and external audit activities
• Provide technical directions to lower-level staff
• Other incidental duties assigned by Leadership

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees