Staff Compliance Validation Engineer
$130,000–$150,000 year
On-site · Brisbane, California, United States
Job Summary
This role involves leading validation strategy and execution across products, software, hardware, and manufacturing processes to ensure compliance with global regulatory requirements. The Compliance Validation Engineer will develop and execute validation strategies, lead qualification activities, and ensure compliance with FDA and ISO 13485 standards. Responsibilities include supporting cross-functional teams, driving validation for manufacturing equipment and processes, and maintaining validation documentation. Requires 8+ years of industry experience and a Bachelor’s degree, with advanced education preferred.
Required Qualifications
- Bachelor’s degree in Engineering, Quality, or a related field
- 8+ years of experience in validation engineering, quality, or compliance within a regulated industry
- Strong knowledge of validation principles, including IQ/OQ/PQ
- Solid understanding of regulatory requirements and quality standards, including FDA regulations and ISO 13485
- Experience with embedded systems, hardware/software integration, and production test methodologies
- Familiarity with supporting NPI, design transfer, and manufacturing process validation
- Proficiency with quality management systems (QMS) and validation documentation practices
- Strong analytical, problem-solving, and organizational skills with high attention to detail
- Excellent communication and collaboration skills
Desired Qualifications
- Enterprise Architect
- Markdown
- Quarto
- PowerShell
- JavaScript
- Typst
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