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Quality Manager

Company: NCX Corporation
Location: Durham
Posted on: November 19, 2021

Job Description:

NCX Corporation True Digital X-Ray Enabled by NanotechnologyQuality Manager Position SummaryNCX Corporation, an innovative company developing next generation X-ray tubes and systems for medical and security applications, is recruiting candidates for a Quality Manager position. This person will be responsible for creating and managing all Quality Systems functions including but not limited to: Management Review, Internal Audits, Complaint Management, CAPA Management, Quality Metrics, Maintaining Certifications and Registrations, Training, Document control, and NCX's Quality System compliance to GMP and ISO requirements (9001/13485/14971).The ideal candidate will be a strong utility player that is able to take on a diverse set of tasks and work with all departments in the organization.Key ResponsibilitiesThe candidate will be responsible for creating and managing all Quality Systems functions for an early-stage X-ray technology development company about to transition to a manufacturing entity. Essential job duties that must be performed with proficiency include: - Create and maintain Quality Procedures, to include Work Instructions, and SOP's - Implement, maintain, and over time improve the quality system to meet or exceed customer, regulatory and ISO requirements - Lead all Regulatory Inspections - Manage, facilitate, and support Management Review activities - Manage, facilitate, and support the Complaints process and activities in response to trends from NCMR/CAPA/Complaints - Function as the Quality department liaison and subject matter expert to customers and regulatory representatives - Propose, implement and enforce quality improvements necessary to establish NCX as a Lean Manufacturing Facility - Responsible for the development and administration of the Employee Training Program. - Manage a staff of personnel, which may include Quality Engineers and SpecialistsQualifications - Minimum 5 years in a Quality Engineering, Quality Systems, or Internal Auditing roles - Experience in creating and implementing a quality system in a Medical Devices manufacturing company preferred - Technical or Life Science degree (BS) or equivalent medical device experience - Solid oral and written communication skills - Certification / membership in RAPS and/or ASQ helpfulWho We AreNCX is an early-stage company in RTP focused on fundamentally reshaping X-ray technology through the design and manufacture of X-ray tubes using carbon nanotubes (CNTs) to produce significantly clearer 3D X-ray images compared to Traditional X-ray Systems.What We Are Looking ForWe are looking for an experienced, energetic self-starter who looks forward to contributing as part of an exciting, highly motivated early-stage company environment. We need your creativity and genius, as well as your commitment as we face the fun and challenges of a high growth, early-stage company. As a small growing company, we are looking for you to be able to take on multiple challenges as they arise and help put together the structure the company needs going forward.We are an equal opportunity employer with a strong commitment to having a diverse and inclusive workplace. We need independent thinkers who can thrive in a high intensity situation while respectfully challenging each other as part of a high functioning team.Job Type: Full-timeBenefits:

  • 401(k)
  • Health insurance
  • Paid time offSchedule:
    • Monday to FridayEducation:
      • Bachelor's (Preferred)Work Location: One location

Keywords: NCX Corporation, Durham , Quality Manager, Executive , Durham, North Carolina

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