Quality Engineer Ii jobs at Boston Scientific in Costa Rica, Cartago

About the role:

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

You're 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.
• 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.
• 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.
• 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.
• 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 decisions.
• 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.
• Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
• 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.

What We’re Looking For:

• Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
• English Level desired: B2 (80-89%)
• Experience: proven experience in Medical or Pharmaceutical industry, working on Quality, Process Development or Engineering Department. Solid knowledge in Statistics, Problem Solving techniques, Quality System, Process and Test Method Validation, Risk Management, Six Sigma or similar.
• Desired knowledge: Product and Process Transfer and Project Management. ASQ certified desired.
• At least 3 years of proven experience in similar position.

Hybrid Roles:

About the Role:

Leads initiatives for the daily support of products, processes, materials, and equipment in order to achieve production goals (i.e., quality, delivery, cost, productivity, and safety).

Your Responsibilities Include:

• May execute the following responsibilities:
• Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing on complex projects to ensure project success.
• Consistently generates innovative and unique solutions to meet department goals.
• Successfully completes complex engineering work and contributes to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, Six Sigma, process study, process improvements, and report preparation.
• Selects process improvement techniques to solve complex problems and make sound equipment and process recommendations.
• Summarizes, analyzes, and draws conclusions from complex test results.
• Designs and prepares complex reports and communicates results to the technical community.
• Designs and coordinates complex engineering tests and experiments.
• Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
• Completes and manages complex Capital Equipment Request Authorizations (CERA’s).
• Leads cross-functional project teams.

What We’re Looking For:

• Desirable Licentiate degree in Mechanical, Electromechanical, Electronic, Biomedical, Chemistry, Industrial Electrical, Industrial Maintenance.
• English Level desired: B2+: 80-89%.
• Desired knowledge: Minitab, Hands on Statistics, Validation Process, Tools (Statistics, Technical Manuals, Kaizen, Six Sigma).
• At least 3 years of experience in similar position.
• Or an equivalent combination of education and experience.

Hybrid Roles:

About the Role:

Leads initiatives for the daily support of products, processes, materials, and equipment in order to achieve production goals (i.e., quality, delivery, cost, productivity, and safety).

Your Responsibilities Include:

• May execute the following responsibilities:
• Works cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing on complex projects to ensure project success.
• Consistently generates innovative and unique solutions to meet department goals.
• Successfully completes complex engineering work and contributes to new product development teams and product support, typically including the following activities: technology development, test of materials or products, preparation of specifications, Six Sigma, process study, process improvements, and report preparation.
• Selects process improvement techniques to solve complex problems and make sound equipment and process recommendations.
• Summarizes, analyzes, and draws conclusions from complex test results.
• Designs and prepares complex reports and communicates results to the technical community.
• Designs and coordinates complex engineering tests and experiments.
• Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
• Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment.
• Completes and manages complex Capital Equipment Request Authorizations (CERA’s).
• Leads cross-functional project teams.

What We’re Looking For:

• Desirable Licentiate degree in Mechanical, Electromechanical, Electronic, Biomedical, Chemistry, Industrial Electrical, Industrial Maintenance.
• English Level desired: B2+: 80-89%.
• Desired knowledge: Minitab, Hands on Statistics, Validation Process, Tools (Statistics, Technical Manuals, Kaizen, Six Sigma).
• At least 5 years of experience in similar position.
• Or an equivalent combination of education and experience.

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.
• 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.
• 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
• 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 and / or approve reports 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
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
• Document investigation findings in analysis report on GCS2
• Become a trainer for the Software related with complaints handling process (GCS2), as required.
• 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
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities
• Provide supervision, leadership, and overall direction to the Quality Release 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, 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: B2:(70-79%).
• Desired knowledge: ASQ certification (CQE, SSGB) desired, 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.
• At least 2 years of experience in similar position.

About the Role

· Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes.

· Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.

· Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.

· Prepares and presents technical data and recommendations at technical reviews.

· Writes validation protocols and reports applicable to new processes.

· Ensures proper documentation is completed to meet quality systems requirements. (e.g., TMVs, OQ/PQ, MVPs, etc.)

· Plan development/execution builds associated with the project using special work requests.

· Develops qualified production lines and utilize lean essential tools to support ramp up and scalability.

· Provides Design for Manufacturability (DFM) input to the engineering print package.

· Contributes ideas to or generates Intellectual Property submissions.

· Trains and/or provides work direction to technicians and may train manufacturing personnel when required as part of a validation.

· May serve as core team member or extended team member on new product projects.

· May serve as a technical mentor or guide for new team members

· Basic project planning skills.

· Good communication skills oral and written

What We’re Looking For:

· Licenciature in Materials Engineering, Mechanical Engineering, Mecatronics Engineering, Electronic-Electrical Engineering, Industrial Engineering, Biomedical Engineering

· English Level required: B2+ (80% - 89%).

- At least 3 years of experience in similar positions

· Desired knowledge: Statistics, Problem Solving, Process Improvement, Project Management, Process Validation, Clinical Knowledge, mechanical design, test automation.

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.
• 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.
• 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
• 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 and / or approve reports 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
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
• Document investigation findings in analysis report on GCS2
• Become a trainer for the Software related with complaints handling process (GCS2), as required.
• 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
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities

What We’re Looking For:

• Licentiate degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
• English Level desired: B2:(80-89%).
• Desired knowledge: Formal Training on statistical and quality techniques desirable, ASQ Certified, Knowledge of Six Sigma, APQP or similar tools.
• At least 5 years of experience in similar position.
• Or an equivalent combination of education and experience.