Summary

This role is responsible for managing the people, processes, and tools in the Quality Assurance department. Develops, implements, maintains, and improves Biocare Medical’s Quality Management System (QMS). Responsible for core QMS processes such as CAPA, change management, documentation systems, management review, complaint investigation and closure, supplier quality management, distributor quality management, planned deviations, and audits management. Work cross functionally to collect data to track/trend and monitor the state of the QMS to assist in planning, defining, implementing, and tracking continuous improvement activities throughout the organization. Work together with the Quality Operations Manager to ensure adherence and compliance to Quality and Regulatory requirements.

Essential Functions

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

• Performs team management functions to include recruiting, performance management, and mentoring. 
• Manages the QMS team’s tasks and assignments.
• Ensures the accuracy and completeness of the QA document control system.
• Coordinates the review and revision of procedures, specifications and forms as well as maintaining and updating the document control and tracking databases.
• Ensures that changes are documented and implemented.
• Coordinates Periodic Procedure Reviews to ensure documents are reviewed, as required.
• Notifies senior management of potential quality issues that might impact product quality.
• Reviews, tracks, closes, and trends compliance/quality issues related to customer complaint investigations.
• Monitors CAPAs to ensure that they are being opened, addressed adequately, and closed in a timely manner.
• Coordinates Quality Management Reviews and reporting.
• Manage the internal/external audit programs to ensure compliance with subject regulations. Setup back and front room and the logistics required for such audits. Perform internal audits.
• Manage the supplier Quality management process and supplier Quality agreements. Perform supplier audits.
• Assists in representing the company in ISO/FDA, notified body, and client audits.
• Track, implement, and monitor remediation activities resulting from audits.
• Prepares training presentations for training within the QA department as well as in other departments.
• Strengthens quality awareness, and actively works cross functionally to provide solutions to help support operational excellence.
• Identifies quality improvement opportunities, compliance concerns, identify, prevent, and resolve deviations.
• Manage the distributor Quality management process and distributor Quality agreements.
• Other duties as assigned by Management.

Competencies

• Bachelor’s Degree with five to ten (5-10) years of management experience in Quality Assurance OR a combination of related experience and relevant advance education required. 
• Leadership and team management experience, including the ability to motivate, mentor, and develop employees is required.
• Training/certification in ISO and GMP or certified auditor highly preferred.
• Proficient in quality management systems with experience supporting CAPA, change management, documentation control, complaints, management reviews, supplier quality management, and QA audits.
• Strong team player working across the organization promoting a quality culture.
• Excellent project management skills, attention to detail, and organizational skills.
• High level of reading comprehension.
• Ability to write clear & understandable documentation with effective presentation of information.
• Independent judgment within broadly defined policies.
• Extensive experience with ISO13485:2016/MDSAP, 21 CFR 820, IVDR/IVDD/cGMP, ISO14971:2019.
• Experience in electronic QMS and implementation is a plus.
• Advanced computer skills required.

Expected Location & Hours of Work

• This is a full-time on-site position.
• 8 a.m. to 5 p.m. Monday – Friday. This position may require working extended weekday or weekend hours depending on business needs.

Compensation Range

• $120,000 - $160,000 annually