Validation Quality Technician Boston MA Contract
Overview
The Validation Quality Technician leads test method validations and process validations to maintain product manufacturing quality standards. This role ensures compliance with ISO 13485 and ISO14971 while supporting design transfer to production. The position involves collaborating with cross-functional teams to achieve full regulatory adherence across the product lifecycle.
What You'll Do6
- 1Execute engineering studies and process validations according to written protocols
- 2Perform gage R&R and attribute agreement analysis for test method validation
- 3Maintain comprehensive quality records following Good Documentation Practices
- 4Serve as quality representative during large-scale remediation efforts
- 5Collaborate with quality engineering to ensure product conformance throughout development
- 6Implement corrective actions based on root cause analysis findings
Requirements5
- 1High School Diploma or GED with quality experience in FDA regulated industry
- 2Proven experience in test method validation for medical devices
- 3Strong proficiency in Microsoft Office suite and database management systems
- 4Excellent organizational skills with ability to work independently
- 5Experience with clean room environments and raw material handling
Salary Insight
$30 - $31k per year
Location
Required Skills
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