What are the responsibilities and job description for the Quality Engineer – II position at Katalyst Healthcares & Life Sciences?
Company Description
- Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
- We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Job Description
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.
Responsibilities:
- 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.
- Analyze 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.
Requirements:
- 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.
Additional Information
All your information will be kept confidential according to EEO guidelines.
