JT774 - SR. QUALITY ENGINEER

Quality Consulting Group • Juncos, PR

8d

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 Mechanical, Electrical or Chemical preferred (not Science)
• Minimum of 5 years of relevant experience on field (quality – excluding experience laboratory micro/chemistry) or engineering or programming.
• Experience in Change Control of Medical Devices.
• Basic knowledge in Probability and Statistics (preferably using Minitab).
• Knowledge of equipment Commissioning/Qualification.
• Knowledge of Process validation and Computer software validation (e.g. requirements flow down from design to manufacturing).
• Knowledge of Manufacturing, Packaging and Laboratory equipment.
• Technical experience (Troubleshooting) or any similar experience or background.
• Knowledge of Quality/Process Control/Assurance of Medical Devices.
• Investigation and root cause analysis skills.
• Experience with Risk management documentation: pFMEAs.
• Experience investigating manufacturing operations events in support to product disposition.
• Experience assessing and tracing manufacturing defects/rejects trends.
• Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence).
• Organization and Communication skills.
• 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).

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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees