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Quality Assurance Manager

3 months ago

Thousand Oaks, California, United States Accordance Search Group Full time

We are currently seeking a candidate with ISO FDA 21 CFR part 820 experience

About the Company: Company XYZ is a leading provider in the medical device industry, dedicated to ensuring top-notch quality products are consistently manufactured.

  • Must be a great collaborator with strong communication skills
  • Transitioning to Greenlight Guru EQMS; experience with Greenlight Guru or Oracle is advantageous
  • Assistance needed for process improvement
  • Preferably holds an Engineering degree or relevant experience
  • Will be responsible for managing a team of 4 individuals (2 full-time employees and 2 contractors)

Responsibilities:

  • Lead the Quality Affairs team
  • Develop, enhance, and maintain processes and procedures to ensure top-tier product designs and consistent product quality
  • Ensure efficient incoming inspection; collaborate with suppliers to enhance quality standards
  • Establish strong collaborations with R&D, manufacturing, marketing, sales, and regulatory departments
  • Guarantee compliance with relevant FDA and ISO standards

Qualifications:

  • Hold a Bachelor's degree in Engineering or Science
  • Minimum of 8 years of experience in a regulated environment (preferably in the medical device sector)
  • At least 2 years of direct supervision of quality employees

Desired Knowledge, Skills, and Abilities:

  • Excellent problem-solving and critical thinking abilities
  • Effective written and verbal communication skills
  • Demonstrates a proactive approach to tasks
  • Emphasizes continuous improvement
  • Projects a strong leadership presence
  • Prior experience with Oracle would be beneficial