Quality Specialist

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, Company 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 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!

 Responsibilities:

• Perform, according to the Company’s 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

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.

 You will receive a confirmation email stating your application has been submitted. Once your application has been reviewed, you should receive an update on your status via email. Please keep an eye on your spam and junk mail. Please no phone calls regarding the position.

If you are unable to submit your application, please email the recruiting department at [email protected] for assistance.