Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
The Quality Engineer I plays a key role in maintaining product quality, compliance, and process control for medical device manufacturing. This position ensures adherence to regulatory standards, drives continuous improvement initiatives, and supports post-market surveillance activities. The engineer collaborates with cross-functional teams to investigate product and process issues, develop risk-based solutions, and ensure ongoing product conformance and customer satisfaction.
Responsibilities:
- Develop and execute quality and control plans to ensure product conformance and manufacturing continuity.
- Lead investigations into production and customer quality issues to determine root cause and implement corrective and preventive actions (CAPA).
- Perform hands-on troubleshooting of manufacturing nonconformities and customer-returned devices.
- Monitor and analyze product performance using statistical and risk-based methodologies.
- Prepare and maintain technical documentation related to investigations, nonconformities, and complaints.
- Communicate complex technical issues and solutions effectively to internal stakeholders.
- Ensure compliance with Quality System Regulations (QSR), company policies, and applicable international standards (FDA, ISO 13485, etc.).
- Support audits, inspections, and continuous improvement initiatives.
- Participate in cross-functional quality projects and contribute to risk management and process improvement activities.
Requirements:
- Bachelor's degree in engineering (Biomedical, Mechanical, Electrical, or related discipline).
- Minimum 2 years of relevant experience in a regulated industry (medical device or FDA environment preferred).
- Strong knowledge of FDA regulations, including 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 803 (Medical Device Reporting).
- Familiarity with ISO 13485 standards and other applicable regulatory requirements.
- Proficiency in root cause analysis, risk management, and quality tools (FMEA, CAPA, 8D, etc.).
- Excellent communication, analytical, and problem-solving skills.
- Proficient in project management and data analysis techniques.
- Experience in post-market surveillance or complaint handling.
- Working knowledge of statistical software or data visualization tools.
- Green Belt or Lean Six Sigma certification.