Supplier Quality Representative

We are seeking an experienced Supplier Quality Representative to support our team in San Germán, Puerto Rico, on a 3-month professional services project. The primary focus of this project will be the development, review, negotiation, and administration of Quality Agreements with suppliers. The ideal candidate will have strong experience in supplier quality systems within regulated pharmaceutical, medical device, or life sciences environments, along with a solid understanding of applicable FDA and ISO requirements. Key Responsibilities Develop, draft, review, negotiate, and administer Quality Agreements with suppliers. Support the implementation and maintenance of supplier quality management processes and documentation. Ensure Quality Agreements are aligned 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. Qualifications 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 working 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 effectively with cross-functional teams. Strong attention to detail and ability to manage quality documentation and project deliverables. Project Details This is a 3-month external professional services engagement with an estimated immediate start date. The position will be primarily on-site in San Germán, Puerto Rico, with the possibility of remote work on certain days depending on project needs. Compensation $35–$45 per hour for professional services, depending on experience and qualifications. Pay: $35.00 - $45.00 per hour Expected hours: 40.0 per week Application Question(s): How many years of professional experience do you have in Supplier Quality, Quality Assurance, or Quality Systems? Do you have experience developing, drafting, reviewing, negotiating, and administering Quality Agreements with suppliers? Which of the following regulations/standards do you have professional experience with? FDA 21 CFR Part 820 FDA 21 CFR Parts 210–211 ISO 9001 ISO 13485 All of the above Are you available to work primarily on-site in San Germán, Puerto Rico, for a 3-month project starting immediately? Experience: Quality Agreements : 3 years (Preferred) Work Location: In person

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