Quality Control Administrator

Position Summary

The Quality Control Administrator is responsible for reviewing and verifying product documentation to ensure accuracy, completeness, and compliance with applicable quality standards, including ISO 13485 and FDA regulations. This role plays a key part in maintaining product integrity and supporting overall quality assurance processes.

Key Responsibilities

• Adhere to and support all company Quality Management System (QMS) requirements.
• Maintain a clean, organized, and safe working environment at all times.
• Follow established standard operating procedures (SOPs) and detailed work instructions.
• Communicate effectively with team members and cross-functional departments.
• Review Device History Records (DHR) for both production and returned (RGA) products to ensure accuracy and compliance.
• Inspect product labeling to verify correctness and adherence to specifications.
• Prepare Certificates of Conformance (CoC) for production and RGA products.
• Conduct final product inspections and approvals prior to shipment.
• Evaluate sterilization records and related documentation for compliance with regulatory requirements.
• Identify opportunities for process improvements and collaborate with supervisors to implement solutions.
• Participate in special projects and additional assignments as needed.
• Perform other related duties as assigned.

Additional Responsibilities

• Independently verify quality-related work and exercise authority to approve or reject based on established standards.
• Understand that job duties may evolve over time and responsibilities may be adjusted as needed without prior notice.

Qualifications

• 3–5 years of experience in a regulated manufacturing environment; experience within an ISO 13485:2016 environment is strongly preferred.
• Solid mechanical aptitude and technical understanding.
• Strong written and verbal communication skills.
• Ability to collaborate effectively within a team environment.
• High level of attention to detail with a focus on accuracy and compliance.
• Excellent organizational and time management skills.
• Proven problem-solving abilities, particularly in cross-functional settings.
• Ability to manage multiple tasks and meet deadlines efficiently.

Physical Requirements

• Primarily office-based work, including extended periods of sitting and computer use.
• May require standing or walking throughout the facility for extended periods.
• Ability to lift up to 40 pounds as needed.