Cranial Technologies, Inc. · 3 days ago
Quality Specialist
Chandler, AZ
Full-time
Onsite
Entry Level
$50K/yr - $60K/yr
1+ years expCranial Technologies, Inc. is dedicated to researching, diagnosing, and treating plagiocephaly, and they are seeking a Quality Specialist to ensure compliance with FDA regulations and company procedures. The role involves performing internal audits, tracking corrective actions, and maintaining document control for quality policies and procedures.
Medical Device
No H1B
Hiring Manager
Mary Keane
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
Qualification
Required
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
Benefits
Medical, Vision, & Dental insurance
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
Company
Cranial Technologies, Inc.
Cranial Technologies® is the leading global provider for the treatment of infants with plagiocephaly (flat head syndrome).
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Scott Cable
Chief Operating Officer
Jane Renae Devine
Executive Assistant to Chief Executive Officer
Company data provided by crunchbase