QA/RA Manager CTL Amedica - 5.0 Carrollton, TX Job Details Full-time 5 hours ago Benefits Health insurance Dental insurance 401(k) Flexible spending account Paid time off Vision insurance 401(k) matching Life insurance Qualifications ISO certification process Computer operation Accreditation standards (regulatory compliance area) Engineering Continuous improvement Attention to detail Quality improvement Desktop applications Regulatory/legal compliance standards in production Biomedical regulatory compliance Productivity software Team motivation (leadership skill) FDA regulations Full Job Description CTL Amedica is an

ISO 13485

certified and FDA registered Medical Device Company headquartered in Carrollton, Texas. CTL designs, manufactures and distributes medical device products and systems for spinal surgeons; specifically implants and devices.

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. Please submit resumes to

Job Type:

Full-time Benefits:

401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Life insurance Paid time off Vision insurance Ability to

Commute:

Carrollton, TX 75006 (Required)

Work Location:

In person