Jt880 - Sr. Manufacturing Engineer

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:

• Execute equipment & test method validations, preform manufacturing procedure changes.
• Coaches and reviews the work of lower-level specialists; may manage projects / processes. 
• 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. 
• Ensures processes and procedures are in compliance with regulations.
• Typically, an individual contributor with responsibility in a professional discipline or specialty.
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. 
• Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
• Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
• Communication and Influence: Communicates with senior internal and external customers and vendors.
• Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

Qualifications:

• Bachelor's degree in engineering
• 4+ years of experience in related area
• Change control of Medical Devices
• Equipment Commissioning / Qualification
• Process Validation 4. Computer System Validation (CSV)
• Manufacturing, Packaging and Laboratory Equipment
• Technical experience (Trouble shooting) or any similar experience or background
• Quality / Process Control / Assurance of Medical Devices
• Process Validation and Computer software validation knowledge.
• Equipment Validations Manage Supplier Change Requests
• Advise Project Lead
• Mechanical technical lead
• Manufacturing Documentation
• 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.