Quality Engineer I at Boston Scientific Corporation Malaysia

, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

16 Apr, 26

Salary

0.0

Posted On

16 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Root Cause Analysis, CAPA, FMEA, ISO Standards, Statistical Sampling, Process Validation, Technical Drawings, Quality Metrics, Process Improvement, Nonconformance Handling, Minitab, SAP, Power BI, MES, cGMP

Industry

Medical Equipment Manufacturing

Description

May execute the following responsibilities: Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria. Understanding of product quality plans, documents, and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs. Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation. Becomes familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development Learns Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials. Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc. Evaluates new equipment and processes. Get involve in various stages of equipment and processes validations: Run and / or review and / or approve reports I.Q 's, O.Q' s and P.Q 's as well as any other document relating to validation. Read and interpret technical drawings, procedures, and protocols Work with Research and Development to efficiently qualify new components; assist suppliers in creating of statistical sampling plans, inspection methodology and quality procedures for new components Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities Clarify priorities and remove roadblocks to maintain a high level of quality in accordance with ISO standards, cGMP's, Corporate and site level SOP's. Bachelor's degree in Industrial Engineering, Chemical Engineering, Electrical Engineering, Electronic Engineering or any similar English Level desired: B2+ Experience: 2+ years Or an equivalent combination of education and experience. Desired knowledge: ISO485, Power BI, SAP, MES, Minitab, Non conformance handling

Responsibilities

The Quality Engineer I will identify manufacturing process defects and assist in root cause analysis and corrective actions. They will also evaluate new equipment and processes, support validation activities, and work with R&D to qualify new components.