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:

Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.

Coordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.

Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.

Reports on the status of validation activities to fulfill regulatory requirements.

Performs system administration and configuration of quality information technology systems.

Performs investigation non-conformance events

Initiates, recommends, and provides solutions to the Non-Conforming Product as per procedures

Verifies the implementation and effectiveness of non-conforming CAPA

Executes job responsibilities as established in the procedures

Follows the documentation procedures Non- Conformance Resolution

Evaluating, Investigating & Completion of Non- Conformance

Investigation ( Data gathering of Quality issue)

Identify Corrective/Preventive Actions

Implementing Corrective/Preventive Actions

Lead complaint activities with the Operating Units members

Qualifications:

Bachelor in Engineering

2+ years of relevant experience

Knowledge of Good Manufacturing Practices

Lean Six Sigma Green Belt Certification

Microsoft Office (Excel, Word, Outlook, Power Point, Project), Agile, HR - ABRA Suite, Maximo, MRO Program, SAP, TEDS, Agile, Compliance Wire, Gallup On-line Tool

Good oral and written communication skills (English and Spanish)

Availability to work overtime and weekends when necessary

Good problem-solving skills

Availability for 1st shift