Manufacturing Quality Engineer
Katalyst Healthcares and Life Sciences
Job Description:
We are seeking a Manufacturing Quality Engineer to support manufacturing operations by ensuring products meet quality standards, regulatory requirements, and customer expectations. The ideal candidate will drive quality improvements, investigate non-conformances, lead root cause analysis activities, and collaborate with cross-functional teams to maintain a robust Quality Management System (QMS).
Responsibilities:
We are seeking a Manufacturing Quality Engineer to support manufacturing operations by ensuring products meet quality standards, regulatory requirements, and customer expectations. The ideal candidate will drive quality improvements, investigate non-conformances, lead root cause analysis activities, and collaborate with cross-functional teams to maintain a robust Quality Management System (QMS).
Responsibilities:
- Support daily manufacturing operations to ensure compliance with quality standards and procedures.
- Investigate product defects, non-conformances, deviations, and customer complaints.
- Lead root cause investigations using methodologies such as 5 Whys, Fishbone, Pareto Analysis, and FMEA.
- Develop, implement, and monitor Corrective and Preventive Actions (CAPA).
- Analyze quality metrics and identify opportunities for continuous improvement.
- Review and approve manufacturing procedures, work instructions, SOPs, and quality documentation.
- Support process validation, equipment qualification, and change control activities.
- Conduct internal audits and participate in customer, regulatory, and certification audits.
- Collaborate with Manufacturing, Engineering, Supply Chain, Operations, and Quality teams.
- Monitor Statistical Process Control (SPC) data and implement process improvements.
- Ensure compliance with applicable regulations and quality standards.
- Support risk management and quality planning activities.
- Bachelor's degree in mechanical, Industrial, Manufacturing, Biomedical Engineering.
- 3+ years of experience in Quality Engineering, Manufacturing Quality, or Quality Assurance.
- Experience in a manufacturing environment.
- Quality Management Systems (QMS).
- CAPA Management.
- Root Cause Analysis.
- Non-Conformance Management.
- Change Control.
- Statistical Process Control (SPC).
- FMEA (Failure Mode and Effects Analysis).
- Risk Management.
- Process Improvement.
- Data Analysis and Reporting.
- Technical Documentation.
- Experience with:
- ISO 9001
- ISO 13485
- AS9100
- IATF 16949
- GMP/GxP environments
- Knowledge of Lean Manufacturing and Six Sigma methodologies.
- Experience with validation and qualification activities.
- ASQ certifications such as American Society for Quality CQE or CQA preferred.
Vacancy posted 3 days ago
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