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QUALITY ENGINEER (QMS)

Date Posted: 10/3/2020

JOB DESCRIPTION

Spectral MD, Inc.

Position Title: Quality Engineer (QMS)

About Spectral MD, Inc.

 

Spectral MD, Inc.’s mission is to revolutionize wound care using real-time data & Artificial Intelligence. We are doctors, scientists, engineers, and forward-thinkers striving to modernize the management of wound care with our DeepView® Wound Imaging System. Our product is using color and light to innovate wound care to investigate faster, more reliable, and more predictable care.

Position Overview:

Spectral MD, Inc. is seeking a Quality Engineer (QMS) in Dallas, TX. The QMS Quality Engineer supports the Quality Assurance department by continuously maintaining and improving of the Quality System in compliance with applicable regulations and standards.

Primary Duties / Responsibilities:

  • Implement and oversee supplier qualification and monitoring. 

  • Enforce and oversee sufficient supplier quality controls are in place 

  • Provide daily quality system support activities 

  • Support Nonconforming Material program 

  • Provide support in all internal, external, and supplier audit activities 

  • Participate in continuous improvement projects as needed 

  • Implement & maintain policies and procedures to ensure continuous compliance of Spectral MD, Inc.’s Quality Management System. 

  • Implement quality strategies for modified and new product development. 

  • Implement methods and systems to assure that Spectral MD, Inc.’s development, manufacturing and clinical teams receive support in the areas of risk management, design controls including validation and verification testing, corrective and preventative action, root cause analysis, statistical analysis, quality planning and inspection processes. 

  • Oversee product and manufacturing changes (Change Control) for compliance with applicable regulations and potential impact on future and current regulatory submissions. 

  • Participate in the product development process to assure products are designed in compliance with FDA regulations and applicable international quality systems standards 

  • Implement Quality Systems metrics and evaluation processes. Reporting of these metrics to Spectral MD, Inc.’s management team (e.g., Management Review) 

  • Establish and maintain corporate procedures as they relate to the FDA Quality System regulations. ISO 9001, ISO 13485, the Medial Device Directive 93/42 EEC, Medical Device Regulation (EU) 2017/745 

Qualifications:

  • A Bachelor’s degree, or an advanced degree, in engineering, biotech, life sciences, or quality; or equivalent experience. 

  • A minimum of five years Quality Assurance experience in the medical device industry. 

  • Working knowledge of following regulations/standards:

    • Class III and Class II Medical Devices 

    • 21 CFR 820 and ISO 13485 

    • EU MDD (EU MDD 93/42 EEC), Canadian Medical Device Regulations (CMDR); 

    • Risk Management per ISO 14971 

  • Experience working in cross functional organization 

  • Excellent computer skills including Microsoft office suite of products (Word, PowerPoint, Excel, etc.,) 

  • Strong communication and interpersonal skills. 

  • Strong attention to detail 

Additional Qualifications (preferred):

  • Familiarity with following regulations/standards: 

    • Medical Electrical Equipment standards such as IEC 60601 

    • Software Development per IEC 62304 

    • Human factors and usability engineering for Medical Devices 

 

Spectral MD, Inc. is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other characteristic protected by applicable federal, state or local laws. 

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2515 McKinney Avenue, Ste. 1000; Dallas, TX 75201

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