ATL Technology
  • 23-Jul-2019 to 21-Sep-2019 (MST)
  • Quality
  • Springville, UT, USA
  • TBD
  • Salary
  • Full Time

Medical/Dental/Vision/Life/AD&D/STD/LTD - 401K - PTO and small on site gym.

ATL Technology is searching for a professional, knowledgeable and experienced quality manager to be an integral part of our quality team. This role requires an energetic and motivated self-starter with a passion for quality, compliance and continual improvement.

Duties & Responsibilities:

  • Define quality related requirements, lead employees with the processes used to develop, establish, and maintain quality compliance programs, policies, procedures, and controls to ensure that all products conform to cGMPs, established standards, agency regulations, guidelines, and industry compliance trends.
  • Develop ATL personnel through training and the hiring process to support continually increasing requirements supporting new and existing products and regulatory requirements.
  • Proactively endorse the concepts of COQ, COPQ and Six Sigma/Lean.
  • Move the organization to develop Quality by focusing on Quality Assurance, Quality by Design, Validation and Statistical Process Control among other Quality Assurance tools.
  • Effectively prepare the company for successful FDA inspections, certified body and customer audits.
  • Participate as an effective member of local Site Management Team(s) and the Global Quality Management Team, contributing to both Site and Global objectives and initiatives.

If you are interested in the position and have the following experience under your belt;

  • Bachelor's Degree or equivalent combination of education and experience.
  • At least 5 years of experience in a quality environment of a manufacturing environment of medical devices and/or electrical components and assemblies or other regulated industries,
  • At least 5 years management of employees
  • Expert knowledge of ISO 13485 or 9001 with Lead Auditor Certification.

We would be very interested in reviewing your resume.

Extra attention will be given to resumes that have experience with these preferred items.

  • FDA Regulation, specifically 21 CFR Part 820
  • Medical Device Manufacturing
  • Regulatory Communications
  • CAPA
  • ASQ or RAC Certification
  • Clean Area/Room Environment
  • Document/Record Control Systems
  • Root Cause Analysis
  • Sterilization & Packaging
  • Risk Management
  • Validation
  • IPC
  • Statistical Techniques
ATL Technology
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