We’re looking for a unique Quality Specialist who has an excellent ability to communicate well with others and a strong attention to detail. If you are an intelligent, professional, and friendly person with a passion for Quality, we want you on our team!
We are looking for someone that is independent and self directed in their personal work habits. You’ll be working with a team of dynamic employees who are passionate about the work they do and are dedicated to the babies we treat. Our team members enjoy working in an invigorating environment, have an interest in learning in a collaborative setting, and most of all, bring a positive attitude!
Perform regular audits of applicable departments. As part of these audits, the Quality Specialist will:
Determine compliance with FDA’s applicable medical device regulations, company procedures and any other applicable requirements
Identify process improvement or areas of concern
Analyze and document effective corrective and preventive actions.
Track and ensure that all corrective and preventative actions are successfully performed within established timelines.
Maintain internal controls over quality policies and procedures
Log and perform or assist with corrective and preventative actions.
Assist with product inspections as needed
Assist during regulatory inspections.
1 – 2 years experience in Quality Inspection -OR-
1 – 2 years experience in Document Control –OR-
1 – 2 years experience in NCMRs –OR-
1 – 2 years experience in CAPAs (Corrective Actions)
Experience giving feedback while maintaining positive working relationships with co-workers
Ability to multi-task and prioritize
An understanding of and ability to navigate the emotional component of auditing
About Cranial Technologies
Founded in 1986, Cranial Technologies is the only company in the world solely dedicated to treating infants with plagiocephaly. It’s our mission to provide the best possible treatment, experience and outcome for every family who seeks our care. To date, we’ve reshaped the lives of more than 200,000 babies using our proven safe and effective DOC Band®
In 1998, Dynamic Orthotic Cranioplasty®, known as the DOC Band, became the first cranial helmet cleared by the U.S. Food and Drug Administration for plagiocephaly treatment and, a few years later, for plagiocephaly treatment associated with post-surgical correction. Today, the DOC Band is the only device supported by clinical studies and over 25 years of documented outcomes.