Quality Assurance Specialist

Summary/Objective

Understand and apply the Quality Management System requirements and appropriate medical device standards. Responsible for implementing and maintaining one or more quality system processes including, but not limited to CAPA, Nonconformances, Deviations, Complaints and Change Management. Collaborate with and provide technical process expertise to internal groups in the quality management system.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Process Change Control Forms (CCF) requests through the electronic document management system. Follow-up with document owners, reviewers, approvers on pending actions.  Update and maintain CCF Log. Prepare metrics and provide weekly reports.
• Performs customer complaints investigations, reporting, and analysis. Maintains and track customer complaints records and related documentation. Prepare metrics and provide weekly reports.
• Maintain QA Team Ticket system. Prioritize and manage incoming requests to assign appropriate team members. Process requests as assigned. Monitor aging requests to ensure completion. Escalate issues to manager as necessary.
• Maintains the Biocare CAPA system including managing meetings, conducting effectiveness verifications, provide quality review/consultation on investigations, coordinate the activities of CAPA owners, and maintain the CAPA log. Prepare metrics and provide weekly reports.
• Maintains the Biocare NCR, Deviation and Complaints systems including assigning/issuing new numbers, reviewing, and routing forms, maintaining logs, following up with owners on open actions, coordinating meetings, and collecting and  reporting metrics.
• Writes procedures, protocols, plans, and reports as well as maintaining and updating the documents.
• Performs internal/external audits to ensure compliance with subject regulations.
• Prepares training presentations for training within the QA department as well as in other departments.
• Strengthens quality awareness, and actively works with R&D, Manufacturing QC, and technical support departments to provide solutions and improve efforts to provide solutions and improve processes efficiently and operational excellence.
• Identifies quality improvement opportunities, compliance concerns, identify, prevent, and resolve deviations.
• Maintains and tracks QMS programs as necessary, including facilitating the progress of deliverables.
• Other duties as assigned by management.

Competencies

• BS/BA degree preferred
• Two plus (2+) years’ experience in QA disciplines in medical device and/or pharmaceutical industry preferred.
• Training/certification in ISO and GMP, a plus.
• Document Control knowledge and experience with proven ability to successfully deliver projects.
• Working with electronic document management systems, a plus.
• Working knowledge of quality systems.
• Attention to detail and good organizational skills.
• High level of reading comprehension.
• Able to write clear & understandable documentation with effective presentation of information.
• Demonstrates independent judgment within broadly defined policies and ability to lead projects.
• Experience with FDA QSR, ISO 13485, and ISO 14971 requirements.
• Advanced computer skills required.

Compensation Range

• $60,000 to $80,000 Annually

Expected Hours of Work

• 8:00 a.m. to 5:00 p.m. Monday – Friday. This position may require extended weekday or weekend hours depending on business needs.