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