Open Position: Senior Quality Assurance Specialist

Function:  Quality

Summary

EdgeOne Medical is seeking a Senior Quality Assurance Specialist to join our growing organization.  
The role will report directly to the Senior Director Quality in a rapidly growing organization providing Medical Device and Combination Product development Services to an industry leading Client base.

  • Working closely with the Senior Director Quality to drive forward the strategy for the QA department concerning all matters relating to the QMS.
  • Key objectives will be QMS performance monitoring, review and continual improvements towards increased process effectiveness and efficiency.
  • Working cross functionally with Engineering, Quality, Regulatory, & Project Management to develop strong communication and ensure effective coordination of the quality processes across the organization.

Please send your resume and a cover letter to careers@edgeonemedical.com and include Quality Assurance Specialist in the Title.

Accountabilities

  • Be a leading person in the implementation and transformation from paper based to eQMS.
  • Participate in the data preparation and reporting of the respective KPIs and management reports.
  • Establish standards of performance and best practices within the QMS.
  • Be a leading person in the maintenance of the ISO13485 certification as well as planning, hosting, and remediating internal and external audits.
  • Drive continual improvement of the QMS based upon performance and identification of opportunities and risks. Adopting Lean Six Sigma quality principles to continually improve processes for greater effectiveness and efficiency.
  • Responsible for the coordination of Nonconformance, CAPA, Changes Requests, and other quality related activities within the QMS.
  • Responsible for Supplier Quality Management. Lead the qualification and performance reviews of Suppliers. Investigate and coordinate supplier related nonconformities. Perform Supplier audits as required.
  • Responsible for the preparation and delivery of QMS and Quality related training & coaching.
  • Support equipment calibration and maintenance activities.
  • Support the performance of incoming material inspections.
  • Monitor environmental activities and support data filing.
  • Lead development of SaMD QMS requirements.
  • As required, support Clients services with QMS consulting for Medical Devices & Combination Devices.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

 Bachelor or advanced degree in Engineering or Life Science.
•    7+ years' experience in Quality Management System development and management with extensive experience in medical device quality assurance.
•    Experience required with Design Controls, Product Development, and day-to-day management of QMS.
•    Experience in problem solving & process improvement, Lean Six-Sigma training an advantage. 
•    Organized, proactive, analytical thinking, with strong teamwork, communication, and management skills. Ability to accomplish objectives with minimal supervision.
•    Expert knowledge and interpretation of ISO 13485:2016 and 21CFR820.
•    Strong knowledge of Regulation (EU) 2017/ 745, MDSAP, ISO 17025, GDP, GLP and GMP.

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.