Job Description
Job Description
Job Title: Quality Engineer – P4 (12-Month Contract)
Location: Puerto Rico
Engagement Type: Temporary / Contract
Contract Duration: 12 Months
Experience Level: 5+ Years
Function: Quality
Position Summary
Our client is seeking a Quality Engineer (P4) to provide critical support for New Product Introductions (NPI) and product transfers into manufacturing operations. This role ensures that products meet all quality, regulatory, and operational requirements prior to release while supporting successful product launches and lifecycle sustainment.
This opportunity is offered by contract through ProQuality Network and is ideal for professionals with strong experience in FDA-regulated environments and cross-functional collaboration.
Key Responsibilities
- Serve as the Quality Engineering lead for NPI and product transfer activities, ensuring manufacturing readiness and compliance.
- Support technology transfers from development to manufacturing, including review and approval of quality deliverables, risk documentation, and process controls.
- Drive reduction of process defects (scrap, nonconforming materials, complaints) through root cause analysis and CAPA implementation.
- Develop and implement product quality plans, specifications, risk analyses, and FMEAs.
- Establish and maintain process monitoring systems, identifying critical process parameters and implementing controls to reduce variability.
- Analyze and interpret manufacturing and quality data to support product launches, transfers, and continuous improvement initiatives.
- Develop quality tools, training materials, and documentation to support new and transferred products.
- Evaluate systems and processes for compliance with regulatory and internal quality requirements; support audits as needed.
- Support and approve final process monitoring and product release activities prior to distribution.
Experience & Qualifications
- Minimum of 5+ years of experience in Quality Engineering or Process Engineering within an FDA-regulated environment (medical devices, pharmaceuticals, biotechnology, or diagnostics).
- Proven experience supporting New Product Introductions (NPI) and/or product transfers.
- Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), GMP, and ISO 13485.
- Hands-on experience with FMEA, CAPA, root cause analysis, and process monitoring systems.
- Experience collaborating with Manufacturing, R&D, Supply Chain, and Regulatory teams.
- Strong analytical, technical writing, and communication skills.
Quality System Responsibilities
- Demonstrate a strong commitment to patient safety and product quality.
- Ensure compliance with all quality policies, procedures, and regulatory requirements.
- Support the availability of resources (personnel, tools, systems) to maintain Quality System effectiveness.
- Promote a culture of quality and continuous improvement across the organization.
Job Scope & Leveling
- Apply advanced functional knowledge to support complex product launch and transfer activities.
- Work independently under established procedures, with guidance on complex issues.
- Lead or support projects or project phases related to NPI and product transfers.
- Communicate effectively with cross-functional stakeholders and participate in technical discussions and presentations.
If you meet the qualifications and are interested in this opportunity, we invite you to apply through the job description link and submit your most updated resume.