Quality Specialist

About Cranial Technologies

Crani­al Technologies is the only company in the world completely dedicated to researching, diagnosing, and treating plagiocephaly (commonly called flat head syndrome). With over 300,000 babies successfully treated, we are the plagiocephaly experts and the leader in pediatric cranial shaping orthoses.

The Quality Specialist will perform internal audits, ensure compliance with FDA regulations, maintain document control, and support continuous improvement initiatives for the DOC Band® orthotic product.

• Conduct regular audits per the Cranial Technologies audit schedule and determine compliance with applicable FDA regulations, company procedures, and other requirements.
• Analyze audit observations and work with relevant departments to develop corrective and preventive actions.
• Track the completion of corrective and preventive actions within established timelines.
• Assist in executing corrective or preventive actions when necessary.
• Participate in remediation reviews and document results in the CAPA log.
• Maintain internal controls over quality policies, procedures, work instructions, and other company documents, ensuring proper storage and accessibility.
• Facilitate changes to SOPs, policies, and other documents, obtaining required signatures and ensuring proper approval and distribution.
• Assist during regulatory inspections.
• Support the company’s continuous improvement initiatives.
• Perform other duties as needed to support the quality system.
• Ensure confidentiality of patient information and other sensitive data.

• Bachelor’s Degree required.
• At least one year of quality inspection experience within a regulated industry.
• Detail-oriented, organized, and able to multi‑task.
• Effective communication skills in a positive manner.
• Clear, concise written communication.
• Basic computer skills.
• Able to work a minimum 40‑hour week Monday‑Friday, with schedule flexibility as needed.
• Must be able to sit or stand for long periods of time.

• 401(k) retirement plan with company match.
• 3.5 weeks paid time off plus 7 company paid holidays.
• Life insurance.
• Short‑/long‑term disability insurance.
• Pay range: $50,000 – $60,000, dependent on relevant experience.

As set forth in Cranial Technologies’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.