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Quality Assurance Engineer

CTL Medical Corporation d/b/a 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. 

The Quality Assurance Engineer is responsible to provide quality support for manufacturing of products as per cGMP requirements and comply with the established quality management system (QMS). The Quality Assurance Engineer ensures the processes (incoming quality inspections, product quality controls, investigation of customer complaints, supplier quality audits, CAPAs, etc) are adhered to as per ISO13485:2016 and 21CFR 820. 

This position is a hands-on Quality Engineer role that includes equipment and production control activities, as well as direct interfacing with engineering and production teams to optimize and document product design, processes, and controls. The role focuses on efficiency and compliance and demands a proactive approach and clear communication to support the company's growth and success.

 

Duties: 

Nothing in this job description restricts management’s right to assign / reassign duties & responsibilities to this job at any time.

• Supports design assurance engineering as needed with risk management activities and review of design documentation including product design requirements and design verification test & inspection protocols

• Leads product inspection strategy and planning including working with suppliers on purchased product requirements and development of measurement methodologies

• Supports development of in-process and final product testing

• Provides development and implementation support for process verification and validation plans, equipment qualification documents and Validation Plans (Equipment, Product or Process specific plans).

• Support validation process through protocol drafting, approval, and execution and providing validation training and guidance

• Maintain the Master Validation Plan (MVP) and ensure its compliance to applicable date requirements

• Develop & manage the execution of Gauge R&R & Test Method Verification (TMV) protocols & plans. 

• Investigate and resolve quality events such as Nonconformances, CAPAs, Complaints, and Audit findings

• Supports supplier evaluation, auditing, and performance monitoring

• Team member for the transfer of specifications and processes to production during the design transfer phase

• Ensure activities for the quality management systems are in compliance with the regulations such as 21CFR820 and ISO13485 requirements.

• Reviews Device History Records (DHR) and completes product release as applicable

• Trend quality performance metrics and demonstrate continuous improvements including Warranty & Repair, SPC data, Non-Conformance Reporting Trend Analysis (Mfg & Pur), etc.

Essential skills, experience and qualifications: 

  • Standard regulatory requirements such as cGMP / cGDP, ISO13485:2016 and 21CFR820

  • Process Validations i.e. IQ, OQ, PQ, & Software Validation

  • Previous work experience in a quality role within a medical device, biotechnology or pharmaceutical company

  • Demonstrated use of quality tools such as GR&R, pFMEA, Control Chart, Process Capability

  • Knowledgeable of processes such as Quality Management System, Documentation and Record Controls, CAPA, Change Management, Quality Audits, Product Quality Nonconformance, Supplier Quality Management, and Process Validation is required

NON-ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS (not necessary but preferred)

• Certified as Internal Auditor, Quality Engineer (CQE) or Green Belt in Six Sigma is desired.

• Minimum of Bachelor’s Degree in Technical Field (Engineering or Sciences) is desired.

• Microsoft Office Suite.

• Previous Presentation creation and dissemination to Executive Leadership

Job Status: Position is full time 

 
Location: Carrollton, TX 

ONLY CANDIDATES THAT LIVE IN THE DALLAS AREA WILL BE CONSIDERED

PLEASE SEND RESUMES TO jbenvie@ctlamedica.com

CTL Amedica offers a collaborative and inclusive work environment, competitive compensation, and opportunities for professional growth. If you are a creative thinker with a passion for product development and the desire to make a difference in the healthcare industry, we encourage you to apply.

Join CTL Amedica in our mission to advance spinal healthcare through innovation and excellence.

CTL Amedica is an equal opportunity employer, and we welcome candidates from all backgrounds to apply.

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