Hello Professionals, This is Pavan from intellectt.INC.
At present we have a requirement open on Quality Engineer - Ponce, Puerto Rico.
If you are interested, please share your updated resume to ****** or call me at +1 (732) 276-1830 or Please Let me know, by replying to this email
Job Title: Quality Engineer
Location: Ponce, Puerto Rico
Duration: 06+ Months on W2 Contract Experience: 5+ years
Onsite Role Overview: We are seeking a dedicated and experienced Quality Engineer to join our team.
The successful candidate will be responsible for ensuring that our manufacturing processes meet quality standards and comply with regulatory guidelines.
This role requires a proactive approach to identifying areas for improvement and collaborating effectively with cross-functional teams.
Key Responsibilities:
Develop, implement, and maintain robust quality processes and systems to ensure compliance with industry standards. Perform thorough root cause analysis and implement corrective actions for quality-related issues to enhance product integrity. Conduct regular audits to ensure compliance with ISO and FDA standards, identifying areas for improvement and ensuring adherence to quality protocols. Collaborate closely with engineering and production teams to foster continuous improvement in product quality. Oversee non-conformance management processes, including CAPA (Corrective and Preventive Actions) and complaint investigations, ensuring timely resolution and documentation. Support the validation of processes, equipment, and systems to ensure they meet specified quality standards. Monitor and analyze key quality metrics, identifying trends and areas for improvement to drive operational excellence. Qualifications:
Bachelor's degree in Engineering, Quality, or a related field. Minimum of 5 years of experience in quality engineering within a regulated environment. Proven experience with CAPA, Non-Conformance Reports (NCR), and Quality Management Systems (QMS). Strong knowledge of FDA and ISO regulations and guidelines. Excellent attention to detail and strong analytical skills. Exceptional communication skills, both written and verbal, with the ability to effectively collaborate with diverse teams.