Full Time Contract Title: Quality Assurance Contractor Location: On-site at Dorado facility in Puerto Rico. Length of Contract: Minimum of 6 months About Our Client Our client is a global leader in medical technology, dedicated to transforming lives through innovative medical solutions. They develop, manufacture, and market a broad range of cutting-edge medical devices across various specialties, including Cardiology, Urology and Pelvic Health, Endoscopy, Neuromodulation, and Electrophysiology. Position Summary Our client is seeking a detail-oriented Quality Assurance Contractor to join their team on-site in Dorado, Puerto Rico. This full-time contract role, with a minimum commitment of 6 months, is critical for enhancing product and process quality within a highly regulated manufacturing environment. You'll be instrumental in executing vital quality remediation activities, ensuring operations consistently meet and exceed rigorous regulatory standards such as FDA, ISO 13485, and GMP. Responsibilities + Evaluate and Qualify Reworks : Critically assess and qualify product and process reworks, strictly following approved protocols and regulatory requirements to maintain product integrity and safety. + Drive Document Control & Revision : Take ownership of reviewing and revising crucial controlled documents, including SOPs, work instructions, protocols, and batch records, as a core part of remediation efforts. + Conduct Impact & Risk Assessments : Perform thorough impact assessments and risk analyses for nonconformances and historical deviations, providing data-driven insights to guide remediation strategies. + Ensure Documentation Traceability : Meticulously document all changes, ensuring clear traceability and robust justification aligned with internal quality standards and external regulatory expectations. + Foster Cross-Functional Collaboration: Partner effectively with Engineering, Quality Assurance, and Manufacturing teams to gather essential technical inputs and facilitate seamless remediation efforts. + Support CAPA Implementation : Actively participate in root cause investigations and contribute to the implementation of effective Corrective and Preventive Actions (CAPAs) where necessary. + Maintain Rigorous Records : Keep accurate, comprehensive records of all remediation activities, ensuring the timely completion of assigned tasks and contributing to our commitment to data integrity. Qualifications + Experience: A minimum of 2 years of hands-on experience in quality assurance or quality systems within a highly regulated industry (e.g., medical devices, pharmaceuticals, biotech). Previous experience as a contractor in a similar quality remediation role. + Regulatory Expertise: Strong, demonstrated understanding of Good Manufacturing Practices (GMP), FDA regulations, and ISO standards, particularly ISO 13485. + Technical Skills: Proven experience with rework validation, document change management, and risk-based decision-making in a quality context. + eQMS Proficiency: Proficient in using electronic quality management systems (eQMS) and various document control tools. + Attention to Detail: Exceptional attention to detail, strong organizational skills, and the ability to work effectively and independently with minimal supervision. + Language Proficiency: Fluent in both Spanish and English (written and verbal communication) is essential. Education & Certifications + Education: Bachelor's degree in engineering or a related technical field, or equivalent practical experience demonstrating a strong understanding of quality principles. + Preferred Certifications: Certifications in Quality Assurance (e.g., ASQ Certified Quality Engineer, Auditor) are a plus. About RCM: RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America. Equal Opportunity Statement: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job, duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.