Director, Quality Assurance / Regulatory Affairs At Cuattro In Golden, CO
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
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 representative for Cuattro
- Direct supervision of Senior Quality Assurance Software Tester
- 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)
- 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).
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: email@example.com)
with subject Re: Cuattro - Director QA RA job