Position Details
About this role
This role involves managing validation activities, developing validation protocols, and ensuring compliance with healthcare standards to improve operational effectiveness in a medical device manufacturing environment.
Key Responsibilities
- Create and manage validation plans
- Conduct validation tests
- Develop sterilization validation protocols
- Analyze data and report results
- Lead risk analysis
Technical Overview
The position requires expertise in validation processes, statistical analysis, sterilization validation, and familiarity with tools like SAP and Minitab within a healthcare manufacturing setting.
Ideal Candidate
The ideal candidate is a mid-level Quality Engineer with 4+ years of experience in validation processes within the medical device or healthcare manufacturing industry. They possess strong analytical skills, familiarity with ISO 13485 standards, and experience with validation protocols and statistical tools.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Certifications
Preferred
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of validation or sterilization experience, No experience with ISO 13485, Bachelor's degree not in engineering or technical field
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