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.This Senior Manager will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. This role is critical to the success our advanced catheters manufacturing portfolio, where this senior manager will play a key role in the receipt of new product designs, manage a team to develop the manufacturing & inspection processes, guide the transfer of the process into production, and manage the production team that will scale up for production. The senior manager position is unique in that there is responsibility over the NPD process and the production process of the key products for our life-saving delivery systems.How you will make an impact :
Manage the timeliness and effectiveness of highly complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes in the advanced catheters manufacturing area.
Oversee the development of multiple, highly complex manufacturing processes and inspection methods and ensure that they are compliant with quality system requirements.
Create strategies to manage the resources and execution of creating and validating new manufacturing processes (including evaluation of source materials and suppliers) and inspection methods based on engineering principles.
Create strategies for resourcing and planning of design transfers from R&D to NPD, and process transfers from NPD to production.
Plan and support the execution of optimization opportunities of new manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) that support design for manufacturing within the NPD framework.
Plan and support continuous improvement projects within the production framework, including opportunities for re-design/design of highly complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk to patients.
Review and approve technical content of risk management files, changes to quality documents, NCRs, training plans, validation reports, etc.
Develop skills and capabilities of your team, discuss career goals, create goals and objectives to support career path discussions.
Train new hires on documentation, investigation, and corrective actions for NCRs, CAPAs, and quality plans.
Prepare material for quality data reviews and present to leadership regularly.
Collaborate with cross-functional teams to lead implementation of corrective actions, employee support, product containment, quality system improvements, and improved training strategies.
Support internal/external audits of processes, documentation, training records, including coordination of audit activities and presentation of evidence.
Manage workload and training of your team.
What you’ll need:
Bachelor's degree in Engineering or Scientific field plus a minimum of 8 years of experience within Quality, Manufacturing, or R&D; OR Master's degree in Engineering or Scientific field plus 7 years of experience within Quality, Manufacturing, or R&D required; or PhD in Engineering or Scientific field plus 4 years of experience within Quality, Manufacturing, or R&D.
Minimum of 3 years of experience managing people
Minimum of 4 years of experience working in a regulated industry
Experience and strong knowledge of quality systems and manufacturing principles
Demonstrated experience leading and executing validations (i.e. OQ/PQ) and quality actions (i.e. NCR, CAPA)
Proven experience leading cross-functional project teams.
What else we look for:
Engineering degree
Management experience of quality engineers in medical device manufacturing
Demonstrated ability and experience creating, executing, and monitoring corrective actions.
Proven experience utilizing statistical analysis capabilities.
Experience in goal setting, monitoring, and execution to plan.
Ability to manage competing priorities in a fast-paced environment and manage expectations.
Highly driven and accountable, track record of good decision making.
Expert knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards).
Experience with Six Sigma concepts (DMAIC preferred) with the ability to lead projects utilizing these principles.
6 sigma black belt certified.
Certified quality engineer.
Experience in external audits by notified agencies.
Demonstrated track record in facilitating process improvement activities and conflict resolution.
Ability to mentor and guide less seasoned engineers in resolving complex issues in specialized area based on existing solutions and procedures.
Proficient in Microsoft Office Suite and related tools and systems.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
