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:

• Collaborate and communicate with other functions to develop reports and give suggestions and ideas.

• Ensure Process instructions are accurate, effective and support compliance with applicable regulations

• Provide technical expertise to define and implement ideas strategies while optimizing cost, compliance, and effectiveness.

• Ability to understand finance term and perform calculations of scrap, burden, etc.

• Validation activities

• Equipment and or process Ownership

• Collaborate with operators and identify ideas, perform troubleshooting of defects and find root cause

• Provides technical and sustaining engineering support in a manufacturing area; therefore, investigation and root cause analysis skills are required to solve problems or improve effectiveness of job area (inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality).

• Knowledgeable on statistical techniques. In addition, the resource needs to be schedule oriented in order to meet projects objectives and assignments without impacting deadlines and it is really important for the resource to have good writing skills and communication skills in English and Spanish to have successful and productive meetings within a cross functional team.

Qualifications:

• Bachelor degree in Engineering

• 3 to 5 years of relevant experience.

• Quality / Process Control / Assurance of Medical Devices (https://medtronic.vndly.com/vendor/applied-candidates/16127?title=True)

• Extensive knowledge in Excel and Minitab.

• Ability to understand finance terms and able to analyze finance data and information.

• Equipment and Process performance metrics (ex. Yield, Downtime, OEE, etc.)

• Change control assessment and requirements

• Validation, Equipment IQ and Computer software validation knowledge

• Availability for 1st shift

  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.

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