KH
Manufacturing Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
1 month ago
- Regulatory Compliance
- CAPA
- GMP
- Lean Six Sigma
- Risk Management
- FMEA
- SPC
1 month ago
- Responsible for ensuring product quality, regulatory compliance, and process adherence in manufacturing environments by monitoring production activities, managing quality systems, and driving resolution of non-conformances.
- The role involves CAPA management, root cause analysis, audit support, and implementation of continuous improvement initiatives while collaborating with cross-functional teams.
- Monitor manufacturing processes to ensure product quality and compliance with defined standards.
- Manage non-conformances (Client), deviations, and CAPA activities.
- Perform root cause analysis (RCA) and implement corrective and preventive actions.
- Support internal and external audits (FDA, ISO).
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
- Maintain and update Quality Management System (QMS) documentation including SOPs, DHF, DMR, and DHR.
- Collaborate with manufacturing, engineering, and supplier teams to resolve quality issues.
- Drive continuous improvement initiatives using Lean Six Sigma methodologies.
- Perform process monitoring and support validation activities (IQ/OQ/PQ as required).
- Ensure proper documentation and traceability of manufacturing and quality records.
- Bachelor's degree in engineering or a related field.
- Experience in medical device manufacturing preferred.
- Strong understanding of regulatory and quality systems.
- Good communication and cross-functional collaboration skills.
- Manufacturing Quality.
- GMP.
- ISO 13485.
- FDA 21 CFR Part 820.
- CAPA.
- Client.
- Root Cause Analysis (RCA).
- Risk Management (FMEA).
- Statistical Process Control (SPC).
- Audit Compliance.
- Quality Management System (QMS).
- Continuous Improvement.
Manufacturing Quality Engineer · Katalyst Healthcares & Life Sciences