Open Position: Director, Quality Assurance

Function:  Quality Assurance (QA)

Summary

EdgeOne is seeking a Quality Assurance expert to join our growing Quality organization.  This role is a leadership position and represents EdgeOne Medical as the Management Representative responsible for the Quality Management System, including accountability for compliance to quality system requirements for the entire EdgeOne Medical organization.   

Please send your resume and a cover letter to careers@edgeonemedical.com and include Director QA in the Title.

Essential Duties and Responsibilities

  • Managing a Quality Assurance team
  • Maintaining the Quality Management System compliant with applicable current standards and regulations aligned with business needs of a service-based organization  
  • Monitoring the Quality Management System and reporting on its effectiveness
  • Internal and external audits, quality system certifications/accreditations and facility registrations 
  • Quality System activities including, but not limited to CAPA, Training, Document and Change Control, and Supplier Quality 
  • Receipt, shipment and destruction of inventory including test articles, manufacturing materials, and laboratory supplies 
  • Coordination with Engineering for equipment qualification, calibration and maintenance 
  • EHS management of the facility, including laboratory and warehouse. 

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  List knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • Bachelor or advanced degree in Engineering or Life Science. 
  • Expert knowledge and interpretation of ISO 13485:2016 and 21CFR820 
  • Experience managing and applying a quality system in a service based organization 
  • Talented in process development and improvement, as well as identification of process indicators 
  • Strong knowledge of GDP, GLP and GMP
  • Familiarity with ISO 17025, Medical Device Regulation 2017/745 and MDSAP
  • Strong communication skills and well-organized. 
  • Minimum of 10 years of experience demonstrating knowledge of a wide range of Quality Systems activities with at least 5 years specifically in medical device quality systems. 
  • Desired: Experience in development of medical devices/combination products
Equal Employment Opportunity

Discrimination in hiring, promotion and all other employment decisions on the basis of race, color, religion, gender, national origin, age, disability, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other basis protected by Federal, state or local laws is prohibited.