Sr Quality Engineer

Sr Quality Engineer

Provide Process/Quality Engineering support to manufacturing or new product development teams, helping to ensure delivery of highest quality product or new products to the customer.

Your responsibilities include:

• Lead Products & Processes Transfers from a Quality standpoint.
• 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
• Deep 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/PRAs.
• 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 TMVs, I.Q's, O.Q's and P.Q's as well as any other document relating to validation.
• Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• 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, ISO EN 14971 requirements.
• 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.
• 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.
• Is familiar with the internal auditing process.
• 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

What we're looking for:

• Licenciature degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
• English Level desired: B2:(80-89%).
• At least 5 years of experience in similar position.
• Experience in Test Method Validation and/or Process Validation.
• Desired knowledge: Formal Training on statistical and quality techniques desirable, ASQ Certified, Knowledge of Six Sigma, APQP or similar tools.

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life's work.