JT781 - QUALITY ENGINEER II
- Juncos, PR
- Temporal
- Tiempo completo
- Develops, modifies, applies and maintains quality standards.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Develop and implements methods and procedures for inspecting, testing and evaluating products and production equipment.
- Performs statistical analysis.
- Ensures that documentation is compliant with requirements.
- May specialize in the areas of design, production control, product evaluation and reliability, as they apply to product or process quality.
- Performs and/or review process validation (not cleaning processes) and equipment documents: URS, FAT, IQ, OQ, PQ, TMV (not laboratory).
- Bachelor's degree in Mechanical, Electrical or Chemical preferred (not Science)
- Minimum of 3 years of relevant experience on field (quality – excluding experience laboratory micro/chemistry) or engineering or programming.
- Ability to use statistical techniques to analyze data capable of developing/reviewing/approving test plans and reports experience in Medical Devices.
- Investigate and collaborate in the investigation of atypical events to support product disposition PFMEA.
- Ability to Develop/Update PFMEA, Control Plans and Process Flows.
- Basic knowledge in Probability and Statistics (preferably using Minitab).
- Experience in Medical Device industry.
- Familiar with FDA 21 CFR 820, EU 217/745 (EU MDR) and standards: ISO 13485, ISO 14971, IEC 60601.
- Knowledge of Microsoft Office Applications (Wors, Excel, Access, and PowerPoint), and Windows OS.
- Organization and Communication skills (strong written and verbal communication skills).
- Ability to work cooperatively as part of a cross-functional team.
- Knowledge of Process validation and Computer software validation (e.g requirements flow down from design to manufacturing).
- Investigation and root cause analysis skills.
- Experience with Risk management documentation: pFMEAs.
- Experience assessing and tracing manufacturing defects/rejects trends.
- Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence).
- Technical writing knowledge.
- Knowledge in Medical Devices regulations.
- Availability for 1st and 2nd shifts and weekends (it will depend on production schedule – projects will be executed at different time shifts, sometimes on weekends).