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Senior Quality Engineer
Katalyst Healthcares & Life Sciences
- 🇺🇸 United States
- On-site
- Senior
- 7 hours ago
- Lean Manufacturing
7 hours ago
Not enough detail in this posting to match
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.
- 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.
Senior Quality Engineer · Katalyst Healthcares & Life Sciences