Jt320 - Quality Engineer II

Quality Consulting Group • Juncos, PR

1d

About The Position

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.

Requirements

• Bachelor's degree in Engineering ( Mechanical, Electrical or Chemical preferred )
• Minimum of 2 years of Engineering experience
• Knowledge in Medical Devices regulations
• Experience in GMP documentation
• Basic knowledge in statistics ( preferably using Minitab )
• Experience in production line
• Must be available to work all shifts, weekends and overtime
• Availability to work extended shifts (8- 12 hours per shift)

Responsibilities

• Perform and/or review process validation [PV: characterization, OQ, PQ] (not cleaning process)
• Perform and/or review equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory)
• Define validation strategies ( e.g. requirements flow down from design to manufacturing )
• Work with Risk Management documentation: pFMEAs
• Work with projects: design requirements validation, manufacturing controls (not Operational Excellence)
• Investigate manufacturing operations events in support to product disposition
• Assess and trace manufacturing defects/rejects trends
• Execute Design transfer activities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level