Senior Quality Engineer

Job Summary
We are seeking a highly experienced Senior Quality Engineer to support packaging validation, equipment qualification, process validation, and manufacturing quality activities within a regulated manufacturing environment. The ideal candidate will have strong expertise in IQ/OQ/PQ validation, packaging and post-sealing equipment validation, statistical analysis, process capability, and Quality Management Systems (QMS) .

Roles & Responsibilities

• Lead and execute equipment qualification and process validation activities, including IQ, OQ, and PQ.
• Develop and review validation protocols, reports, test procedures, acceptance criteria, and related documentation.
• Support packaging validation, including post-sealing and packaging equipment validation.
• Provide Quality Engineering support to manufacturing operations and troubleshoot process and equipment-related quality issues.
• Perform statistical analysis, process capability studies, and data analysis to evaluate process performance and identify improvement opportunities.
• Support the investigation and resolution of nonconformances, deviations, complaints, and CAPAs.
• Lead or participate in Root Cause Analysis (RCA) using appropriate problem-solving methodologies.
• Develop, review, and implement inspection and testing procedures to ensure product and process requirements are met.
• Ensure manufacturing processes and validation activities comply with applicable Quality Management Systems (QMS), regulatory requirements, and company procedures.
• Support internal, external, and regulatory audits and inspections by providing technical documentation and validation evidence.
• Identify opportunities for Lean Manufacturing, process optimization, and continuous improvement.
• Collaborate with Manufacturing, Quality, Engineering, Operations, and other cross-functional teams to resolve technical and quality issues.
• Provide technical support for equipment/process changes, validation requirements, and manufacturing improvements.
• Prepare and maintain accurate technical and quality documentation in accordance with applicable procedures and regulatory requirements.
• Monitor process performance and recommend corrective or preventive actions based on data and risk assessment.
• Participate in design/process reviews, risk assessments , and change control activities as required.

Education & Experience

• Bachelor's degree in engineering, Quality Engineering, Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Life Sciences, or a related technical field.
• Advanced degree or relevant professional certifications in Quality, Validation, or Engineering are a plus.
• 5+ years of experience in Quality Engineering, Manufacturing Quality, Validation Engineering, Process Engineering, or a related field.
• Experience working in a regulated manufacturing environment, preferably within Medical Devices, Pharmaceuticals, Biotechnology, or other highly regulated industries.
• Experience with packaging validation and post-sealing/packaging equipment validation.