Quality Engineer III at Boston Scientific Corporation Malaysia

Cartago, , Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

20 Mar, 26

Salary

0.0

Posted On

20 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, Manufacturing Process Defects, Root Cause Analysis, Corrective Actions, Customer Complaints, Validation Techniques, Risk Management, Statistical Analysis, Lean Principles, Six Sigma, Technical Drawings, Process Validation, CAPA, ISO Standards, Inspection Techniques, Problem Solving

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 raw material / finish good, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be respons Has the responsibility and independent authority to make decisions related to product quality and material inspectioned in the IQA Laboratory, including the disposition of non-conforming product/material. 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 deci Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints. Responsible for reviewing and developing process validation protocols, process, TM's, 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 , BS EN 14971 requirements (Estándar Internacional para gestión de riesgos en dispositivos médicos). 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 internal customers, other engineering disciplines within and outside of the Site and customers should the need arise. Is familiar with the internal auditing process. Bachelor degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field. English Level desired: B2:(70-79%). Desired knowledge: ASQ certification (CQE, SSGB) desired, Problem Solving, Knowledge of QSR's, Formal training on statistical and quality techniques desirable, Networking, Formal studies in process & product validation is desired as well as thorough understanding of inspection techniques and statistical methods, Scientific tools (e.g. Gage R&R, DOE, process capability, SPC), Formal training on statistical and quality techniques desirable, Knowledge of Six Sigma, Lean, APQP or similar tools. At least 3 years of experience in similar position. CRTA #CTGTA #QACR Requisition ID: 620938 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Responsibilities

The Quality Engineer III 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 material inspection in the IQA Laboratory.