Engineer III, Quality
Boston Scientific
- Heredia
- Permanente
- Tiempo completo
- 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. May be responds.
- 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.
- 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 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
- 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 complies to perform the analysis activities (calibration, safety, cleanliness).
- Lead and provide technical guidance to Quality Engineer, Technician
- Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
- Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
- Is familiar with the internal auditing process.
- Bachelor's degree in chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Field.
- English Level: B2:(80-90%).
- 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. Problem solving. Knowledge of QSR's. Networking. Formal Training on statistical and quality techniques. Knowledge of Six Sigma, Lean, AOQP or similar tools. Execution, decision-making, planning, communication, quality oriented, relationship building, influence. People management.
- At least 3 years of experience in similar position.