Katalyst Healthcares and Life Sciences
Job Description:
- Quality Engineer II is responsible for ensuring that products and processes meet established quality standards and customer requirements.
- This role supports the development, implementation, and maintenance of quality systems in accordance with industry regulations and company standards.
- The QE II will take an active role in root cause analysis, continuous improvement initiatives, and cross-functional quality projects.
- Develop and implement quality plans, process controls, inspection methods, and acceptance criteria.
- Perform root cause analysis and lead corrective/preventive action (CAPA) activities.
- Conduct internal and supplier audits to ensure compliance with ISO 9001, AS9100, or other relevant standards.
- Collaborate with Engineering, Manufacturing, and Supply Chain to resolve quality issues and improve product/process performance.
- Manage non-conformances including MRB, deviation requests, and customer complaints.
- Analyse quality data and KPIs to identify trends, drive improvements, and report findings to leadership.
- Assist in the development and review of quality-related documentation such as FMEAs, control plans, and PPAPs.
- Support new product introductions by ensuring quality requirements are met during design and development stages.
- Participate in continuous improvement and lean manufacturing initiatives (e.g., 5S, Kaizen, Six Sigma).
- Provide training and guidance to quality technicians and other staff as needed.
- Bachelor's degree in engineering, Quality, or a related technical field.
- 1-3 years of experience in a quality engineering role in a manufacturing environment.
- Working knowledge of quality systems and standards such as ISO 9001& AS9100
- Experience with root cause analysis tools (e.g., 5 Whys, Fishbone, 8D).
- Proficiency with Microsoft Office and quality software (e.g., Minitab, QMS systems).
- Strong communication and problem-solving skills.