Senior Quality Validation Specialist

About the role

The Senior Quality Validation Specialist will be responsible for ensuring that all products and processes meet high-quality standards. This includes conducting thorough validation studies, reviewing documentation, and providing guidance to ensure compliance with regulatory requirements.

Responsibilities

• Conducts validation studies for new and existing products and processes
• Reviews and audits documentation to ensure compliance with quality standards and regulations
• Provides technical guidance to cross-functional teams to ensure product quality and regulatory compliance
• Participates in internal and external audits as needed
• Develops and maintains validation protocols and procedures

Requirements

• Bachelor's degree in a related field (e.g., engineering, biology, chemistry)
• Minimum 5 years of experience in quality control/validation
• Experience with FDA regulations and guidelines
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

Qualifications

• Knowledge of statistical analysis and data interpretation
• Experience with quality management systems (QMS) such as ISO 13485 or ISO 9001
• Proficiency in Microsoft Office Suite

Skills

• Strong knowledge of quality assurance principles and practices
• Ability to manage multiple projects simultaneously
• Experience with Six Sigma or other quality improvement methodologies
• Good understanding of regulatory requirements and industry standards

Benefits

• Competitive salary commensurate with experience
• Health insurance coverage
• Paid time off
• Professional development opportunities
• Flexible work schedule

Pay

Salary range: $70,000 - $90,000 per year

Schedule

Full-time position, Monday through Friday, 8:00 AM - 5:00 PM