Provide Quality Engineering operational support for the product and technology transfer activities and run operation for Component manufacturing operations.
**Key Responsibilities**:
- Maintain and run operation of components, parts, subassemblies processes includes process and product, process equipments, measurement system & inspection and inspection tooling, fixtures or gauges.
Ensure operational process operating and meeting process/ product requirement/ specification.
Perform inspection and disposition of products.
Troubleshoot (failure mode analysis) and recommend resolution (cause and effect analysis) of any deviations or non conformances relative to process, products and equipments.
Provide proper documentation in NCR/ CAPA system.
- Perform process & equipment start up, set up and trending of quality indicators.
Execute Test Method Validation (TMV), MSA/ GR&R and validation protocol.
Provide training to inspectors, operators and other manufacturing personnel.
Write/ update manufacturing SOP, inspection plan, check list and test methods, Quality SOP, Drawing
Write/ update instruction steps of manufacturing process.
- Other incidental duties
**Education and Experience**:
H.S.
Diploma or equivalent in Technical Degree preferred Required
**Additional Skills**:
- Analytical, Problem Solving and Teamwork Skills
- technical skills in engineering tools/equipment (e.g.
Microscope/ Vision Measurement System, Calipers, Tensile Strength Tester, etc.)
- Able to work independently and as part of a team
- Detail Oriented, Proficient in Oral and Written Communication
- Knowledge of Statistical Process Control is preferred
- Basic Understanding of Lean and Six Sigma Tools is preferred
- Knowledge of USFDA QSR/ cGMP, ISO 13485, ISO14971 is preferred
- 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
About Edwards Lifesciences
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 13,000 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.
COVID Vaccination Requirement
**For United States Applicants Only**:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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