Quality Engineer, III (TURNO C) at Boston Scientific Corporation Malaysia

La Asunción, Cantón de Belén, Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

0.0

Posted On

08 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Root Cause Analysis, Corrective Actions, Preventative Actions, Customer Complaints, Process Validation, Statistical Analysis, Lean Principles, Six Sigma, Technical Drawings, CAPA, NCEP, Failure Mode Investigations, Risk Management, ISO Standards, QSR

Industry

Medical Equipment Manufacturing

Description

Identifies and resolves complex exceptions to work assignments. Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings. Read and interpret technical drawings, procedures, and protocols 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. Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product. Participates in Customer Complaints investigation for areas under their control. Document investigation findings in analysis report on GCS2 Become a trainer for the Software related with complaints handling process (GCS2), as required. Continually seeks to drive improvements in product and process quality. 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. Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decision. Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints. Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects. Knowledgeable on Risk Management, BSEN 14971 requirements. Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes. May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements. Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality. Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanliness). Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff. Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives. Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise. Is familiar with the internal auditing process. Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field 3+ years of related work experience or an equivalent combination of education and work experience English language required B2: 70-79% Please submit Resume in English ASQ certification (CQE, SSGB) desired Problem Solving Knowledge of QSR's Formal training on statistical and quality techniques Knowledge of Six Sigma, Lean, APQP or similar tools Scientific tools (e.g. Gage R&R, DOE, process capability, SPC)

Responsibilities

The Quality Engineer identifies and resolves complex exceptions to work assignments and participates in customer complaints investigations. They are responsible for making decisions related to product quality and driving improvements in product and process quality.