RT
Quality Remediation Contractor
RCM Technologies, Inc. | Life Sciences / Data & Solutions
Location not stated
Mid level
1 week ago
- CAPA
- GMP
- Change Management
- Risk Management
- FMEA
- Veeva
- Windchill
1 week ago
Job Title:Quality Remediation Contractor
Length of Contract: 12 Months
Location: Dorado, Puerto Rico
Job Summary
We are seeking experienced Quality Remediation Contractors to support critical quality remediation activities within a regulated manufacturing environment. Contractors will handle assessing and executing remediation tasks including rework qualification, controlled document revision, CAPA support, historical deviation risk assessments, and compliance improvements in strict alignment with applicable regulatory standards (e.g., FDA 21 CFR Part 820/211, ISO 13485, GMP).
Responsibilities
- Rework Qualification & Assessment: Evaluate and qualify product and process reworks following approved validation protocols, quality standards, and regulatory requirements.
- Document Revision & Control: Review, draft, and revise controlled documents (e.g., SOPs, Work Instructions, Validation Protocols, Batch Records) as part of targeted remediation workflows.
- Risk & Impact Analysis: Support technical impact assessments and risk analyses for nonconformances, historical deviations, and change controls.
- Traceability & Compliance: Ensure all quality system changes are thoroughly documented with audit-ready traceability and technical justification aligned with FDA and ISO standards.
- Cross-Functional Collaboration: Partner with Engineering, Manufacturing, Quality Control, and Supply Chain teams gather technical data and execute action items.
- CAPA & Root Cause Execution: Assist in root cause investigations and execute corrective and preventive action (CAPA) plans as assigned.
- Quality Records Maintenance: Keep meticulous records of all completed remediation tasks to ensure timely project milestone completion.
Qualifications
- Experience: Minimum of 2–4 years of direct experience in Quality Assurance, Quality Systems, or Compliance within a regulated manufacturing environment (Medical Devices, Pharmaceuticals, or Biotechnology).
- Strong working knowledge of cGMP, FDA regulations (21 CFR Part 820 / Part 211), and ISO 13485 standards.
- Hands-on experience with rework validation/qualification, document change management, and risk management (ISO 14971 / FMEA).
- Proficiency with Electronic Quality Management Systems (eQMS) such as TrackWise, Veeva, Windchill, or MasterControl.
- Strong organizational skills, high attention to detail, and ability to drive tasks to closure independently.
- Languages: Fully bilingual (Proficient in English and Spanish, written and spoken).
- Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, Biomedical), Life Sciences, or a related technical field.
Equal Opportunity Employer:
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.
About RCM:
RCM is publicly traded on Nasdaq under the symbol RCMT. RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial.
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.
Quality Remediation Contractor · RCM Technologies, Inc. | Life Sciences / Data & Solutions