Supplier Quality Representative

About the role

CIQA Computer Integration of Quality Assurance - Official is seeking an experienced Supplier Quality Representative for a 3-month professional services project in San Germán, Puerto Rico. The primary focus is developing, reviewing, negotiating, and administering Quality Agreements with suppliers. The role supports supplier quality systems in regulated pharmaceutical, medical device, or life sciences environments and requires an understanding of applicable FDA and ISO requirements.

Responsibilities

• Develop, draft, review, negotiate, and administer Quality Agreements with suppliers.
• Support implementation and maintenance of supplier quality management processes and documentation.
• Ensure Quality Agreements align with applicable regulatory requirements and internal quality standards.
• Collaborate with internal Quality, Engineering, Procurement, and other stakeholders to establish and maintain supplier quality requirements.
• Review supplier-related quality documentation and identify gaps or areas requiring clarification.
• Provide quality support related to supplier management and quality systems.
• Maintain accurate documentation and records associated with supplier quality activities.

Requirements

• Bachelor’s degree in Engineering, preferably Chemical, Industrial, Mechanical, Biomedical, or a related engineering discipline.
• Demonstrated experience in Supplier Quality or a related Quality Assurance/Quality Systems role.
• Strong knowledge of FDA 21 CFR Part 820 and 21 CFR Parts 210–211.
• Knowledge and practical experience with ISO 9001 and ISO 13485.
• Extensive experience with supplier quality management systems.
• Proven experience developing, writing, negotiating, and administering Quality Agreements with suppliers.
• Experience in regulated pharmaceutical, medical device, biotechnology, or other life sciences environments is highly preferred.
• Strong written and verbal communication skills.
• Ability to work independently and collaborate.

Datos clave

• The project is a 3-month professional services project in San Germán, Puerto Rico.
• The primary focus is developing, reviewing, negotiating, and administering supplier Quality Agreements.
• A bachelor’s degree in Engineering is required, preferably in a listed engineering discipline.
• Strong knowledge of FDA 21 CFR Part 820 and 21 CFR Parts 210–211 is required.