Quality Engineer III

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%) 

• Availability to work in our Heredia and Cartago Sites

• 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.