Boston Scientific Quality Engineer II 

Costa Rica 

321288472

Your Responsibilities Include:

• 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.
• Key contributor to process risk analyses execution and reviews. May own process risk files creation.
• 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 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 approve reports: TMVs, 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
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.
• Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, supporting decision making on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.
• 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.

What We’re Looking For:

• Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Field.
• English Level required: B2:(70-79%).
• Desired knowledge: 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).
• Desired knowledge in Product and Process Transfer and Project Management.
• ASQ certified desired.
• At least 2 years of experience in similar position.