Job Summary
Experience/Education:
- Bachelor?s degree in Chemical or Mechanical Engineering, Chemistry, or a related engineering discipline.
- 3+ 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.
How to Apply
Interested candidates should submit their application online using the link below.
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