Quality Specialist

Cranial Technologies•Chandler, AZ

10d•$50,000 - $60,000

About The Position

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. Cranial Technologies, located in Tempe, AZ manufactures the DOC Band®, a cranial orthotic product that is custom-made to each baby’s head. The DOC Band® is the first FDA approved head band to correct cranial asymmetry. 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! The Quality Specialist is responsible for performing internal audits according to established procedures, ensuring compliance with FDA regulations, Cranial Technologies procedures and any other applicable requirements. The position is responsible for identifying and tracking any corrective actions from these audits and will be responsible for implementing some of these actions directly. The position is also responsible for document control for the company, facilitating changes to SOPs, policies, and other documents. We are looking for someone who is independent and self-directed in their personal work habits. You’ll be working with a dynamic group of 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!

Requirements

Bachelor's Degree required
At least one year of quality inspection experience within a regulated industry
Must be detail oriented, organized, and able to multi-task
Ability to communicate effectively in a positive manner
Ability to write in a clear, concise manner
Basic computer skills
Ability to work a minimal 40-hour week Monday-Friday, with variations to schedule as needed
Must be able to sit or stand for long periods of time
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Responsibilities

Perform, according to the Cranial Technologies’ audit schedule, regular audits of applicable departments. As part of these audits, the Quality Specialist will 1) determine compliance with applicable FDA regulations, Company procedures and any other applicable requirements and 2) identify process improvements or areas of concern
Analyze any observations identified during audits and work with applicable departments to generate and document effective corrective and preventive actions
Track and ensure that all corrective and preventative actions are successfully performed within established timelines
Assist or perform corrective or preventative actions as necessary
Participate in the remake reviews and document the results in the CAPA log
Maintain internal controls over quality policies, procedures, work instructions and other company documents, ensuring that they are stored properly and available as necessary
Facilitating changes to SOPs, policies, and other documents, within the established time period
This includes obtaining signatures and ensuring the proper approval process is followed for all document/process changes as well as ensuring proper distribution
Assist during regulatory inspections
Support the company’s drive for continuous improvement
Assist with other requests in support of company and quality objective
Assist with Inspection, Acceptance Activities and Quality’s calibration/verifications
Assist with other areas of the Quality System as necessary
Ensure confidentiality of patient information and other sensitive data