Experience in medical device manufacturing preferred
Strong understanding of regulatory and quality systems
Good communication and collaboration skills
Responsibilities
Monitor manufacturing processes for product quality and compliance
Manage non-conformances and CAPA activities
Perform root cause analysis and implement corrective actions
Support internal and external audits
Ensure compliance with FDA and ISO standards
Maintain and update Quality Management System documentation
Collaborate cross-functionally to resolve quality issues
Drive continuous improvement initiatives using Lean Six Sigma methodologies
Benefits
Opportunity to work in a dynamic manufacturing environment
Involvement in cross-functional teams and projects
Professional development through continuous improvement initiatives
Potential for growth within the organization
Full Job Description
Job Summary:
Responsible for ensuring product quality, regulatory compliance, and process adherence in manufacturing environments by monitoring production activities, managing quality systems, and driving resolution of non-conformances.
The role involves CAPA management, root cause analysis, audit support, and implementation of continuous improvement initiatives while collaborating with cross-functional teams.
Roles & Responsibilities:
Monitor manufacturing processes to ensure product quality and compliance with defined standards.
Manage non-conformances (Client), deviations, and CAPA activities.
Perform root cause analysis (RCA) and implement corrective and preventive actions.
Support internal and external audits (FDA, ISO).
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
Maintain and update Quality Management System (QMS) documentation including SOPs, DHF, DMR, and DHR.
Collaborate with manufacturing, engineering, and supplier teams to resolve quality issues.
Drive continuous improvement initiatives using Lean Six Sigma methodologies.
Perform process monitoring and support validation activities (IQ/OQ/PQ as required).
Ensure proper documentation and traceability of manufacturing and quality records.
Education & Experience:
Bachelor's degree in Engineering or a related field.
Experience in medical device manufacturing preferred.
Strong understanding of regulatory and quality systems.
Good communication and cross-functional collaboration skills.
