Quality Engineer
Katalyst Healthcares and Life Sciences
Job Summary:
We are seeking an Quality Complaint Investigation to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated medical device manufacturing environment. The role involves analyzing quality data, conducting root cause investigations, supporting CAPA activities, and ensuring compliance with FDA and GMP standards
Responsibilities:
We are seeking an Quality Complaint Investigation to support complaint investigations, quality system activities, and continuous improvement initiatives within a regulated medical device manufacturing environment. The role involves analyzing quality data, conducting root cause investigations, supporting CAPA activities, and ensuring compliance with FDA and GMP standards
Responsibilities:
- Review customer complaints and associated service data to determine risk levels and identify problem/cause codes.
- Conduct complaint investigations and perform detailed root cause analysis.
- nalyze data from quality systems including Complaints, Field Corrective Actions (FCA), FDA MDRs, and other quality inputs to identify trends and systemic issues.
- Prepare investigation summaries, reports, and recommendations based on analysis.
- Review existing investigation reports and identify GMP compliance gaps.
- Support development and implementation of corrective and preventive actions (CAPA).
- Drive continuous improvement initiatives and process control activities.
- Conduct data analysis using statistical and quality tools.
- Support maintenance activities for existing product lines and quality systems.
- Collaborate cross-functionally to improve product quality and compliance standards.
- Bachelor's Degree in Engineering (B.E./B.Tech or equivalent).
- 1-3 years of experience in the Medical Device industry.
- Knowledge of FDA Quality System Regulations (21 CFR 820) and cGMP requirements.
- Experience in complaint handling, investigations, and root cause analysis.
- Familiarity with CAPA processes and quality systems.
- Strong analytical and problem-solving skills.
- Experience with statistical tools/software such as Minitab is a plus.
- bility to read and interpret technical drawings and engineering documentation.
- Proficiency in MS Office tools (Excel, Word, PowerPoint) and databases.
- bility to manage multiple tasks and projects effectively.
- Experience with ANSI/ISO/ASQC standards.
- Exposure to continuous improvement methodologies and process controls.
- Knowledge of medical device regulatory environments and compliance practices
- FDA-regulated manufacturing environment.
- Temperature and humidity-controlled workspace.
- May require use of static-protective equipment while in designated work areas.
- bility to sit for extended periods.
- Good hand-eye coordination and dexterity.
- bility to lift up to 40 lbs when required.
Vacancy posted 2 days ago
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