Overview
On Site
Full Time
Skills
Management
GMP
Collaboration
Quality Assurance
Research and Development
Manufacturing
Risk Assessment
FMEA
Documentation
Regulatory Compliance
ISO 9000
IQ
OQ
PQ
ISO 13485
Good Manufacturing Practice
Root Cause Analysis
Corrective And Preventive Action
Auditing
Job Details
Job Description:
Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to manage component selection, supplier coordination, and quality documentation to ensure compliance with FDA, ISO 13485, and GMP standards.
Roles & Responsibilities:
Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to manage component selection, supplier coordination, and quality documentation to ensure compliance with FDA, ISO 13485, and GMP standards.
Roles & Responsibilities:
- Component validation activities including creation and execution of IQ/OQ/PQ protocols and reports.
- Collaborate with cross-functional teams (QA, R&D, Manufacturing) to evaluate and qualify new components.
- Conduct risk assessments (FMEA) and support design and process changes.
- Coordinate with suppliers for part approval, PPAPs, and validation documentation.
- Ensure all validations meet regulatory compliance (21 CFR Part 820, EU MDR, ISO 14971.)
- Support CAPA and non-conformance investigations related to component failures.
- Validation protocols (IQ, OQ, PQ.).
- Component qualification and material review.
- Regulatory knowledge (FDA, ISO 13485, cGMP.)
- Root cause analysis, CAPA.
- Supplier qualification and audits.
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