QA/RA Manager

POSITION SUMMARY

Responsible for providing leadership to the Quality/Regulatory staff and for supporting Quality/Regulatory activities throughout the organization. Responsible for reviewing and interpreting Quality/Regulatory requirements based on regulations and standards and providing compliance directions to the organization. The QA/RA Manager will be the primary interface with external regulatory agencies and certification/notified bodies.

DUTIES AND RESPONSIBILITIES

• Develop Quality System department goals and objectives with associated operating budget to support department activities and corporate initiatives.
• Build a strong Quality Systems team by hiring qualified candidates, establishing and actively managing performance expectations.
• Prepare and deliver training and orientations on global quality system requirements and company processes to employees.
• Interface with FDA, EU notified bodies, Authorized Representatives, certification bodies, and government agencies, as necessary to ensure currency of applicable regulatory requirements and standards. Coordinate external audits and inspections from FDA, EU notified bodies, certification bodies, and other government agencies as required. Assist with registration activities and formulate/communicate responses to audit or inspection findings.
• Plan, coordinate, and execute quality system internal audits and supplier assessment/audit activities.
• Manage Non-Conforming Material processes to appropriately disposition non-conforming product and drive corrective actions.
• Manage Corrective and Preventive Action (CAPA) activities, including investigation, implementation, and effectiveness verification.
• Support complaint handling and post-market surveillance activities, including applicable regulatory reporting.
• Establish/maintain compliant product labeling processes.
• Manage product release activities.
• Review drawing/document changes for compliance with applicable regulations and standards.
• Manage, develop, and provide leadership to Quality/Regulatory staff.
• Other duties as assigned.

ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS

• Bachelor’s degree in Engineering, Life Sciences, or a related technical/scientific discipline.
• 5-10 years of relevant experience in the medical device industry; staff management experience preferred.
• Strong knowledge, understanding, and experience implementing FDA Quality Management System Regulation (QMSR), ISO 13485:2016, and ISO 14971. Must be able to interpret device law into workable, efficient, and effective practices and procedures.
• Experience serving as Quality System Management Representative preferred.
• Experience implementing Unique Device Identifier requirements for medical devices.
• Expertise with process/software validation, Gage R&R, and process capability preferred.
• Effective technical/leadership skills; decisive, strategic, and able to lead, motivate, and inspire others.
• Exceptional computer skills, including operation of Microsoft Office applications.
• Previous experience in the spine and/or orthopedic medical device industry preferred.

Job Status:

• Full Time, Monday through Friday

Location:

• CTL Amedica Headquarters – 2052 McKenzie Drive, Carrollton, TX 75006

Company Benefits:

• Opportunity for advancement, 401k, Great health plans, Dental and vision coverage, Paid sick days, holiday and vacation days