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Quality Assurance Manager

CTL Medical Corporation d/b/a CTL Amedica is an ISO 13485 certified, and FDA registered Medical Device Company headquartered in Addison, Texas. CTL designs, manufactures, and distributes medical device products and systems for spinal surgeons; specifically implants and devices. 

 

We are seeking an experienced Quality Assurance Manager with a strong background in regulatory compliance to join our dynamic team.  This role involves overseeing our quality assurance processes, ensuring compliance with industry regulations and maintaining the highest standards of quality in all our operations.

Duties: 

(Please note: This job description is dynamic and subject to evolve.  Our management team may occasionally modify or add to your duties and responsibilities, ensuring alignment with the evolving needs of our company and the role)

  • Develop, implement, and manage quality assurance policies and procedures to ensure compliance with regulatory standards.

  • Conduct regular internal audits and reviews to assess compliance with regulatory requirements and identify areas for improvement.

  • Coordinate with various departments to ensure quality standards are integrated throughout all processes.

  • Stay updated on industry regulations and standards and ensure the company’s practices align with these requirements.

  • Manage the preparation and submission of regulatory agency applications, reports, or correspondence,

  • Build, lead, and/or mentor a team of quality assurance professionals, providing guidance and support in their roles.

  • Investigate and resolve compliance problems, questions or complaints received from other units in the company, customers, government regulatory agencies, etc. compliant product labeling process. 

  • Conduct risk assessment and implement risk management strategies.

  • Prepare and present detailed Post Market Surveillance and Management Review Reports on quality and compliance activities, findings, and recommendations.

  • Other duties as assigned.

 

Qualifications: 

  • Bachelor’s degree in a relevant field (e.g., Engineering, Life Sciences)

  • 3-5 years of experience in Quality Assurance and Regulatory Compliance in the medical device industry preferable in spine orthopedics.

  • Must have CQA (Certified Quality Auditor) certification or in-training.

  • Knowledge of FDA regulations 21 CFR Part 820, ISO 13485, MDR, and other regulatory standards.

  • Strong analytical and problem- solving skills.

  • Excellent communication and leadership abilities.

  • Ability to work cross-functionally and manage multiple projects simultaneously.

  • Ability to adapt to changing priorities.

  • Ability to travel on demand as needed.

Job Status: Position is full time 

 
Location: Addison, TX

 

Company Benefits:

  • Opportunity for advancement

  • 401k

  • Great health plans

  • Dental and vision coverage

  • Paid sick days

  • Holiday and vacation days

ONLY CANDIDATES THAT LIVE IN THE DALLAS AREA WILL BE CONSIDERED

PLEASE SEND RESUMES TO FLAZAROW@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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