SmartPractice

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Quality Assurance Associate

at SmartPractice

Posted: 11/20/2019
Job Status: Full Time
Job Reference #: 1442
Keywords: database

Job Description

Our Quality Assurance Associate provides general support to the quality team with the preparation, editing, reviewing and approval of QA documents. This position also supports maintenance of QA documents and controlled database files for our Class 1 medical device and diagnostics. This position also assists the QA Manager in coordinating and conducting training interventions to meet quality standards

 


Responsibilities
- Assist in the development and maintenance of the Quality Management System and document management system (MasterControl) to assure compliance to all applicable statutory and regulatory standards including cGMP/QSR, ISO 13485:2016 and 21CFR820, and MDD/EU MDR
- Plan, promote and participate in change control operational activities including the creation, maintenance and compliance of standard operating procedures, work instructions, purchasing specifications, incoming inspection records, inspection/quality plans, etc. Assist in document workflows, reviews, and approvals
- Participate in customer and third-party audits and inspections related to conformance to ISO 13485:2016, processes, safety procedures, product quality, trading partner qualification, Drug Supply Chain Security Act compliance, National Association of Boards of Pharmacy (NABP) inspections, and FDA inspections
- Responsible for maintaining and updating design history files and manage new product development activities and documentation
- Manage complaints and adverse event reporting and assist in coordination and documentation of investigation activities, root cause analysis, regulatory review, and response to customers
- Responsible for managing and administering online and in-person training related to the QMS, regulatory compliance, and safety
- Participate in licensing renewal activities
- Serve as a team lead for Corrective Actions and Preventive Actions projects

 

Qualifications
- Minimum of a bachelor's degree in a related field preferred
- Minimum of 3 years of experience in Quality, Compliance, or Regulatory Affairs with similar duties required
- Experience in reading and creating technical documents required
- Proficient in MS Word and Excel
- Experience with US FDA regulations and guidelines (21 CFR Part 820, ISO 13485:2016, MDD/EU MDR)
- Understanding of QMS software, databases, and document/change control software

 

In support of our mission statement, "Healthier Practices, Healthier Patients", we have adopted a tobacco-free environment and we choose not to hire tobacco and nicotine users. EEO/AA/M/F/Disability/Vet

 

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!