Director, Quality Assurance / Regulatory Affairs At Cuattro In Golden, CO

Published
Company: Cuattro
Department: Operations Management
  • Cuattro provides world class digital radiography software, hardware and integrated systems.
  • Cuattro operate worldwide; offering solutions to Medical and OEM customers
  • A Smarter direction in Digital Radiography. one exposure. one image. one minute
Position: Director, Quality Assurance / Regulatory Affairs
Type: Full Time
Location: 150 Capital Dr Suite 280, Golden, CO (posibile Hybrid or remote)
ROLE AND RESPONSIBILITIES
  • The ideal candidate will develop corporate Quality and/or organizational policies and authorizes their implementation,
  • Including the development and implementation of the Quality System throughout Cuattro.
  • The position has direct responsibility for day-to-day quality inspection, quality process inspection, quality testing, software quality testing, service quality, system reliability and vendor improvement.
  • In addition, the position is responsible for ensuring compliance with the appropriate sections of 21 CFR.
  • The candidate will be responsible in directing cross-functional quality improvement. Develops, implements, and ensures the adherence to quality policies and requirements for all engineering designs.
  • Assists product support area in the gathering and analysis of customer field data.
  • Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
MANAGEMENT RESPONSIBILITIES
  • Management representative for Cuattro
  • Direct supervision of Senior Quality Assurance Software Tester
JOB RESPONSIBILITIES (summary see Linked or Full job Description PDF)
  • Participates with other senior managers to establish strategic plans and objectives.
  • Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people.
  • Performs analysis of complex issues related to product performance and reliability
  • Partners with Technical Support to establish and maintain system to collect and analyze customer experience data with Cuattro products
  • For others see Linked-in job Description or Full job Description PDF (links below)
PREFERRED SKILLS
  • Proficient with the use of classical Quality tools such as
    • Root Cause Analysis,
    • Statistical Process Control,
    • Process Flow Value Analysis,
    • Six-Sigma DMAIC concepts,
    • Probability concepts/Statistical inference,
  • Deep knowledge of 21 CFR Parts 803, 806, 820, 1000.
  • Knowledge/experience with US FDA premarket submission (510(k)) process
  • Medical Device Single Audit Program (MDSAP).
Other detail on
Linked-in Job Description Director, Quality Assurance / Regulatory Affairs
Full PDF Job-Description Director, Quality Assurance / Regulatory Affairs

To apply see Linked-in Job Description Director, Quality Assurance / Regulatory Affairs
or contact: Matthew L. Taylor (email: matthewlt1@msn.com)
with subject Re: Cuattro - Director QA RA job
News Boulder Section 01/20/2023 7:20am CST

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