Quality Engineer

Experience/Education:Bachelor’s degree in Chemical or Mechanical Engineering, Chemistry, or a related engineering discipline.2+ years of experience in a quality or manufacturing role within a regulated environment.Strong project management and communication skills with a track record of delivering results in fast-paced settings.Quality systems and regulatory requirements, including cGMP and 21 CFR Parts 210 & 211.Familiarity with SAP, KNEAT, InBatch, or similar plant/quality systems.

Position Summary: The Quality Engineer plays a key role in ensuring product quality, compliance, and consumer satisfaction by acting as a liaison between Plant Operations, Engineering, Implementation & Support, Category Technical Managers, and the broader Innovation team.

This position requires a hands-on, detail-oriented professional who thrives in a fast-paced manufacturing environment.

The Quality Engineer will actively support plant operations, drive continuous improvement, and promote quality standards through strong cross-functional collaboration and internal/external stakeholder engagement.

Operational Quality Support:Serve as the daily quality point-of-contact for plant operations, participating in Standard Daily Meetings and Internal Quality Area Meetings.Maintain a visible presence on the production floor to monitor quality conditions and support real-time issue resolution.Lead or support continuous improvement initiatives focused on enhancing product quality, compliance, and efficiency.

Quality Systems & Change Control:Ensure quality systems are properly configured and updated to align with current and upcoming production needs.Review and approve changes related to product specifications, processes, packaging, labeling, and formulas.Act as a key reviewer in the Management of Change process to ensure product integrity and regulatory compliance.

Cross-Functional Collaboration:Partner with Operations, Procurement, Engineering, Business Units, and external vendors to align quality standards and resolve technical challenges.Support site initiatives including validation reviews, pre- and post-launch meetings, and submission of stability samples.

Process Validation & Controls:Manage the site’s validation program, including risk assessments, protocol development (IQ/OQ/PQ), and maintaining the Validation Master Plan.Oversee Cleaning & Sanitization validation activities in coordination with engineering and quality teams.

Training & Compliance:Lead training sessions on Good Manufacturing Practices (GMP), validation procedures, and quality standards.Participate in internal and external audits and support site readiness activities.

Continuous Improvement & Problem Solving:Utilize tools such as CAPA, Change Control, Control Charts, Deviation Notices, and Root Cause Analysis to identify trends and drive corrective actions.Lead product inspections, quality trials, and support Quality Key Performance Indicators (KPIs). Technology Transfer:Manage site-specific quality requirements during technology transfers, ensuring alignment with applicable Quality Standards.