Senior Manager, Quality Engineering (Metals)

Edwards Lifesciences

4d

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 Senior Manager, Quality Engineering position is a unique career opportunity that could be your next step towards an exciting future. The Sr. Manager, Quality Engineering for Metals will manage Quality Engineers that focus on supporting Metals Operations, ensuring medical device quality compliance and that controls are in place to guarantee product safety for patients. How You'll Make an Impact: Metals Production Quality Engineering Responsibilities Production Support and Line Downtime Minimization Oversee the Quality Engineers (QEs) responsible for supporting daily production activities. Focus on reducing line downtime by actively managing site Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and Engineering Change Requests (ECRs) related to both production and process validation. Metric Definition and Monitoring Define and lead the development of Tier Metric indicators across all levels of the organization. Conduct Metals Quality Reviews and provide inputs for Site Quality Data Reviews. Identify and implement preventative actions based on ongoing monitoring of production metrics. Collaboration and Process Improvement Partner with Manufacturing Engineering (ME) and Operations teams to review real-time process monitoring data. Initiate improvement projects based on analysis of process inputs and outputs. Prioritize improvement initiatives using risk-based approaches such as A3, Six Sigma Black Belt methodologies, and related tools. Inspection, Control Methods, and Risk Management Assess the capabilities of inspection and control methods, implementing improvements to lower control risk levels. Perform Test Method Validations (TMVs) as needed to ensure ongoing process reliability. Risk Assessment and CAPA/NCR Management Manage process Failure Mode and Effects Analyses (pFMEAs) to facilitate accurate risk assessments for CAPAs, NCRs, and customer complaints. Lead the development and execution of CAPA and NCR strategies, and provide mentorship and coaching to engineers involved in these activities. Investigation and Product Release Lead investigations into Product Risk Assessments (PRAs) and complaints related to manufacturing issues. Support product release activities, including process validation, to ensure compliance and product quality. Process Characterization, Validation, and Audits Understand Metals Chemistry and support process characterization and validation activities aimed at improving process capability. Participate in internal line and process audits, as well as external audit roles, providing technical expertise and support. Material Quality and Product Disposition Manage material quality control, including PRA, Complaint investigations, containment and stop-ship decisions. Assess and make disposition decisions for products on hold, such as those marked with Material Review Board (MRB) or yellow tags. Technical Support and Software Validation Provide technical support during both internal and external audits. Oversee process and equipment software validation and governance to ensure compliance with regulatory requirements. Sterilization and Systems Validation Support the qualification and requalification of sterilization cycles, focusing on product impact rather than microbial aspects. Contribute to the validation of critical systems, especially for point-of-entry corrective maintenance activities. Talent Development and Team Leadership Coach and mentor team members, fostering talent development and succession planning. Encourage accountability and continuous learning, while striving to attract top talent in advanced quality manufacturing. 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. The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. 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. 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.

Requirements

• Bachelor's Degree in related field, related experience in engineering or equivalent work experience based on Edwards criteria
• Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry or equivalent work experience based on Edwards criteria
• Demonstrated track record in management of technical and/or engineering disciplines or equivalent work experience based on Edwards criteria

Nice To Haves

• Experience working in a regulated industry or equivalent work experience based on Edwards criteria
• Certified Quality Engineer
• Six Sigma Black Belt/Lean Black Belt
• Proven project management, leadership and medical device audit leader 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
• Expert 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 and coaching experience for design of experiments, process capability studies, failure mode and effects analysis, statistical process monitoring/control, test method design for manufacturing 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
• Demonstrated audit experience, technical writing experience and assuring documentation compliance
• 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

Responsibilities

• Oversee the Quality Engineers (QEs) responsible for supporting daily production activities.
• Focus on reducing line downtime by actively managing site Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and Engineering Change Requests (ECRs) related to both production and process validation.
• Define and lead the development of Tier Metric indicators across all levels of the organization.
• Conduct Metals Quality Reviews and provide inputs for Site Quality Data Reviews.
• Identify and implement preventative actions based on ongoing monitoring of production metrics.
• Partner with Manufacturing Engineering (ME) and Operations teams to review real-time process monitoring data.
• Initiate improvement projects based on analysis of process inputs and outputs.
• Prioritize improvement initiatives using risk-based approaches such as A3, Six Sigma Black Belt methodologies, and related tools.
• Assess the capabilities of inspection and control methods, implementing improvements to lower control risk levels.
• Perform Test Method Validations (TMVs) as needed to ensure ongoing process reliability.
• Manage process Failure Mode and Effects Analyses (pFMEAs) to facilitate accurate risk assessments for CAPAs, NCRs, and customer complaints.
• Lead the development and execution of CAPA and NCR strategies, and provide mentorship and coaching to engineers involved in these activities.
• Lead investigations into Product Risk Assessments (PRAs) and complaints related to manufacturing issues.
• Support product release activities, including process validation, to ensure compliance and product quality.
• Understand Metals Chemistry and support process characterization and validation activities aimed at improving process capability.
• Participate in internal line and process audits, as well as external audit roles, providing technical expertise and support.
• Manage material quality control, including PRA, Complaint investigations, containment and stop-ship decisions.
• Assess and make disposition decisions for products on hold, such as those marked with Material Review Board (MRB) or yellow tags.
• Provide technical support during both internal and external audits.
• Oversee process and equipment software validation and governance to ensure compliance with regulatory requirements.
• Support the qualification and requalification of sterilization cycles, focusing on product impact rather than microbial aspects.
• Contribute to the validation of critical systems, especially for point-of-entry corrective maintenance activities.
• Coach and mentor team members, fostering talent development and succession planning.
• Encourage accountability and continuous learning, while striving to attract top talent in advanced quality manufacturing.

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: Mid Level
• Number of Employees: 5,001-10,000 employees