Sr. Quality Engineer Cartago at Boston Scientific Corporation Malaysia

Cartago, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

14 Apr, 26

Salary

0.0

Posted On

14 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Manufacturing Process Defects, Root Cause Analysis, Corrective Actions, Quality Plans, Risk Analyses, FMEAs, Process Improvement, Quality Metrics, CAPAs, Validation Protocols, Technical Drawings, Statistical Sampling, Inspection Methodology, Six Sigma, APQP

Industry

Medical Equipment Manufacturing

Description

May execute the following resposibilities: 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 and participates in the transfer of new products. 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 Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness). Document investigation findings in analysis report on GCS2 Become a trainer for the Software related with complaints handling process (GCS2), as required. 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 Bachelor's degree in chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field English Level required: B2+ (80% - 89%). Desired knowledge: ASQ certification (CQE, SSGB) desired, Problem Solving, Formal training on statistical and quality techniques desirable, Knowledge of QSR´s, Networking, Knowledge of Six Sigma, APQP or similar tools, Formal studies in process & product validation is desired as well as thorough understanding of inspection techniques and statistical methods.

Responsibilities

The Sr. Quality Engineer will identify manufacturing process defects and assist in root cause analysis and corrective actions. They will also evaluate new equipment and processes, participate in validation activities, and support quality improvement efforts.