QUALITY SYSTEM MANAGEMENT:

• Assist in maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485, FDA, and other regulatory requirements.
• Ensure compliance with company SOPs and regulatory standards, including GMP (Good Manufacturing Practices) related to ETO sterilization.

QUALIFICATIONS/ EDUCATION:

• Bachelor’s degree in a relevant field (e.g., engineering, chemistry, biology) or equivalent experience.
• Proven experience in quality control, quality assurance, or a related field.
• Experience with ETO sterilization processes and associated quality standards.
• Familiarity with regulatory requirements (OSHA, FDA, EPA, ISO standards) related to sterilization.
• Knowledge of QMS, Good Manufacturing Practices (GMP), and CAPA systems.
• Excellent problem-solving skills.
• Strong communication and interpersonal skills.
• Attention to detail and a commitment to accuracy.
• Proficiency in using quality control tools and software.
• Prior experience in healthcare is preferred.

Physical Demands:

• This position may require long periods of sitting or standing.
• Minimal lifting required.
• Use of fingers, hands, or feel objects.
• Climb stairs.
• Stand, sit, stoop, kneel, and crouch.
• Close vision and depth perception.
• Willingness to travel to supplier locations for audits and assessments.

Work environment:

• Must be comfortable working in a controlled industrial environment, adhering to strict safety protocols.
• Requires compliance with PPE standards for ETO sterilization facilities.

The ETO Facility QA position is responsible for supporting the quality assurance processes and ensuring the proper functioning of the ETO sterilization facility. This role focuses on maintaining compliance with regulatory standards, monitoring sterilization cycles, ensuring product quality, and managing documentation. The position works closely with production, engineering, and regulatory teams to ensure a seamless and compliant sterilization process.
Responsibilities: