Job Description
Overview
We are seeking a Quality Analyst with hands-on experience in medical device manufacturing environments to support production and sustaining quality operations. This role is critical in ensuring product quality, compliance, and continuous improvement across manufacturing processes.
Key Responsibilities
- Perform production floor inspections to ensure compliance with quality standards and regulatory requirements
- Review and approve Lot History Records (LHR) and inspection documentation for accuracy and completeness
- Support component qualification activities, including validation and documentation
- Create, investigate, and resolve Non-Conformance Reports (NCRs)
- Conduct root cause analysis and implement corrective and preventive actions (CAPA)
- Collaborate with cross-functional teams (Manufacturing, Engineering, Quality) to resolve quality issues
- Analyze quality data using tools like Excel and Minitab to identify trends and drive improvements
- Ensure adherence to GMP, ISO, and regulatory standards within the manufacturing environment
Required Qualifications
- Proven experience in medical device manufacturing quality
- Strong exposure to production floor quality inspection
- Hands-on experience with component qualification processes
- Expertise in NCR writing, investigation, and closure
- Experience reviewing LHRs and inspection records
- Proficiency in data analysis tools (Excel, Minitab)
- Strong understanding of quality systems and regulatory compliance
Nice to Have
- Experience with MasterControl (QMS system)
- Exposure to change control processes
- Strong troubleshooting and problem-solving skills
Disclaimer: This job listing is sourced from LinkedIn and is provided for informational purposes. Apply directly through the employer’s application process. Medical Device Navigator is not affiliated with the hiring company.