Boston Scientific TURNO C Quality Engineer II HEREDIA 

Costa Rica 

817399695

Costa Rica-Heredia

Hybrid Roles:

Your Responsibilities Include:

• 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.
• Knows and interprets Risk and Validation documentation to make sound decisions on potentially non-conforming product.
• Lead and provide guidance in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, and complaints
• Get involved in various stages of equipment, process and test method validations: Run and / or review and / or approve reports protocols and reports.
• Read and interpret technical drawings, procedures, and protocols
• Knowledge of statistical tools: SPCs, Capability Analysis, ANOVA, sampling plans, and others to make quality decisions on potentially non-conforming product.
• Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems.
• 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
• Provide supervision, leadership, and overall direction to the Quality team to ensure they are identifying issues, quarantining defective product, and efficiently moving product through the release process.
• Clarify priorities and remove roadblocks to maintain a high level of quality in accordance with ISO standards, GMP's, Corporate and site level SOP's.

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

What we're looking for:

• Bachelor or Licentiate degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field
• English Level desired: 70%.
• Experience: At least 2 years, Non conformances handling, CAPA, Quality manufacturing engineering, risk management, validations, and process engineering.
• Skills: teamwork, proactivity, goals oriented.
• Desired knowledge: ASQ certification (CQE, SSGB) desired, Problem Solving, Knowledge of QSR’s, Formal training on statistical and quality techniques desirable, Networking.
• Please submit Resume in English