Senior Manager, Quality Engineering; Metals

Position: Senior Manager, Quality Engineering (Metals)

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.

What You'll Need (Required):

• Bachelor's Degree in a related field with related experience in engineering

• Regulated industry experience

What Else We Look For (Preferred)

• 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…