Quality Assurance Specialist

Summary/Objective

Responsible for providing guidance in new product development following the procedure and regulation requirements. Perform internal audit to ensure compliance with quality programs, policies, processes, procedures, and that the performance and quality of products conforms to Biocare's Corporate Quality requirements as well as to FDA QSR, ISO, and other global regulations.  Coordinating activities related to product development, internally and externally.  Ensure product manufacture and release in compliance with Company's Quality System. 

Essential Functions

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

• Process 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 Equipment Calibration/Preventive Maintenance 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 with Five plus (5+) years’ experience in QA disciplines in medical device or pharmaceutical industry.
• Auditor experience is required.
• Experience with New Product Development and Product Realization highly desirable.
• Training/certification in ISO and GMP preferred. 
• Advanced computer skills required.
• Working knowledge of quality systems, design control and QA audit.
• 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.

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.