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Edwards Lifesciences

Develops transcatheter heart valves and devices

Receiving Inspection Engineering & Inspection Manager

Inspection & TestConfirmed live in the last 24 hours
Full-timeLimerick, IrelandNo salary listedIn-person

About the Job

Requirements

  • A bachelor's degree in Science, Engineering, or a related technical field, with relevant quality engineering, manufacturing quality, or receiving inspection experience.
  • People-leadership experience in a regulated manufacturing environment.
  • Experience with inspection operations, measurement systems, technical drawings and specifications, including Geometric Dimensioning and Tolerancing (GD&T).
  • Experience supporting internal audits and external regulatory inspections in a medical-device or similarly regulated industry.
  • Demonstrated delivery of cross-functional projects and operational improvements.
  • Strong knowledge of quality engineering, receiving inspection, current Good Manufacturing Practice (cGMP), and applicable ISO/EN requirements.
  • Knowledge of inspection techniques, measurement-system principles, process capability, Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), and statistical methods.
  • Ability to lead inspection-method and automated or vision-system development and validation.
  • Strong people, project, communication, negotiation, problem-solving, and stakeholder-management skills.
  • Ability to use performance metrics, Lean, and Six Sigma methods to improve compliance, service, flow, and productivity.
  • Proficiency with Microsoft Office and relevant quality or manufacturing systems, such as JDE or equivalent.

Responsibilities

  • Lead Receiving Inspection Engineering and Inspection Operations to ensure incoming components and devices meet approved specifications, regulatory requirements, and company quality standards; maintain accountability for engineer and inspector performance, compliance, capability, capacity, and continuous improvement.
  • Lead RI Engineers and the RI Supervisor, setting clear priorities, objectives, and accountability across the receiving inspection organization.
  • Ensure safe, compliant, and responsive execution of visual, dimensional, and functional receiving inspection.
  • Provide oversight of inspection methods, measurement systems, equipment, validation, and technical problem-solving.
  • Ensure inspection records, system transactions, material identification, segregation, storage, and movement meet approved requirements.
  • Ensure nonconforming incoming material is identified, contained, documented, assessed, and escalated in a timely, risk-based manner.
  • Own receiving inspection resource, capacity, training, qualification, cross-training, talent, and succession plans.
  • Define and review metrics for safety, quality, compliance, service, capacity, productivity, ageing, and right-first-time performance.
  • Lead projects and continuous-improvement initiatives that strengthen compliance, improve material flow, and reduce inspection cycle time.
  • Partner with Operations, Supply Chain, Supplier Quality, Engineering, and Quality Systems to resolve issues and support business priorities.
  • Maintain audit readiness and ensure effective implementation of changes involving new products, suppliers, components, or inspection methods.
  • Delegate daily inspection execution and inspector coaching to the RI Supervisor while retaining management accountability.
  • Make risk-based priority and resource decisions within approved quality-system and business requirements.
  • Escalate significant quality, compliance, safety, capacity, or material-flow risks.
  • Coach and develop the team, manage performance and employee relations with HR support, and build succession coverage.

Desired Qualifications

  • Experience managing a supervisor.

About the Company

Edwards Lifesciences

Develops transcatheter heart valves and devices

Edwards Lifesciences focuses on cardiovascular medical technologies, especially transcatheter heart valves. Its products enable repairing or replacing diseased heart valves through minimally invasive procedures rather than open-heart surgery. The company builds on a long history that began with the Starr-Edwards valve and now centers on valve therapies and related diagnostics to treat heart disease. It differentiates itself by specializing in valve technologies and transcatheter approaches, backed by a track record of clinical leadership and global reach. The goal is to improve patient outcomes by providing safer, less invasive valve treatment options for people around the world.

Company size
10,001+
Company stage
IPO
Headquarters
Irvine, CA
Founded
1958

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