Quality Validation Engineer

Overview

One of our large Medical Device companies is seeking a Quality Validation Engineer for a large project. The Quality Validation Engineer will lead and support validation and qualification activities for heat-seal processes and related raw materials, ensuring compliant execution of IQ/OQ/PQ documentation, robust change control, and alignment with the Quality Management System (QMS).

• Author, review, and execute qualification documentation (IQ/OQ/PQ protocols and reports) for material processes, ensuring traceability to requirements and acceptance criteria.
• Lead and support implementation, qualification, and validation of new raw materials and process changes for production lines.
• Support process characterization activities by preparing test strategies, data collection tools, and executed test records; compile, analyze, and summarize results to support qualification conclusions.
• Manage and support change control activities (change requests/records), including impact assessment, risk assessment (e.g., FMEA), implementation actions, and required documentation updates.
• Review, maintain, and improve controlled documents (quality procedures, test methods, and specifications) in support of process and product validation.
• Ensure qualification/validation packages are complete and compliant, including executed protocols, deviation documentation, investigations, final reports, and approvals per the QMS.
• Provide technical input to investigations, deviations, nonconformances, and CAPAs, including containment/bounding, root cause analysis, action effectiveness, and timely closure.
• Ensure day-to-day activities align with applicable requirements (FDA 21 CFR 820, ISO 13485, GxP) and support internal/external audits through documentation readiness and response support.

• Education:
  
  Bachelor’s in engineering;
  Primary focus areas:
  Materials, Mechanical, Industrial, Chemical Engineering or equivalent.
• Years of
  
  Experience:
  
  Minimum 2-5 years of significant engineering and/or operational experience is required.
• Hands-on experience supporting validation deliverables and technical documentation (DOE, IQ/OQ/PQ protocols and reports).
• Experience conducting nonconformance investigations, root-cause analysis, and CAPA support.
• Experience in a regulated industry (medical device preferred) with familiarity with FDA expectations. Six Sigma certification (Green Belt/Black Belt) is a plus.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

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