Jt781 - Quality Engineer II

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• 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).

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.