Quality Engineer in Puerto Rico

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Job DescriptionJob Description

Title: Quality Engineer – Process Development

Location: Puerto Rico

Schedule: 100% Onsite

Purpose Statement

The Quality Engineer will develop and review documentation and procedures while providing automation systems testing and validation support for Process Development and/or Manufacturing Process Engineering activities.

Key Responsibilities

• Support process and equipment validation activities (IQ, OQ, PQ), process performance qualification (PPQ), and the development of Master Validation Plans for new processes or products.
• Review process validation protocols and reports, and support cross-functional teams during validation activities.
• Collaborate with the Process Development team to ensure efficient qualification of new processes; assist with statistical sampling plans and other development procedures.
• Design and develop in-process and receiving quality systems for new processes and components.
• Define gauges, tools, and equipment required for newly developed test methods.
• Identify and control manufacturing process defects (scrap, non-conforming material, customer complaints) by participating in root cause analysis efforts and implementing corrective and preventive actions. May be responsible for querying and bounding data to support complex release criteria.
• Develop product quality plans, specifications, and documentation in partnership with product development team members. May also be responsible for creating risk analyses and FMEAs.
• Develop process monitoring systems by identifying critical process steps and applying methods to reduce process variability and eliminate defect causes.
• Lead process improvement initiatives by establishing methods to capture quality metrics and performing analysis to support sustaining product design and new product development.
• Assist in the creation and enhancement of Quality Tools and Training Materials by evaluating current tools and identifying opportunities for improvement.
• Evaluate system adequacy and compliance of operations and practices against regulations and internal procedures. May serve as an auditor for assigned areas of the Client's Quality System, including development and manufacturing.

Quality System Requirements

• Demonstrate a strong commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.
• Ensure adequate resources (personnel, tools, etc.) are in place to support Quality System compliance and adherence to the client's Quality Policy.
• Promote a work environment that supports and reinforces a culture of quality.

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