Demo

Quality Engineer

cGxPServe
Camden, NJ Full Time
POSTED ON 3/9/2025
AVAILABLE BEFORE 6/5/2025

Responsibilities :

  • Coordinate, assist in developing, and manage reviews and revisions of production Failure Mode Effects Analysis (FMEA) and control plans.
  • Investigate quality problems, determine root causes, and develop corrective and preventive action plans in collaboration with the team.
  • Assist Engineering with the validation and verification of new equipment and processes.
  • Design, develop, and execute both manual and automated tests to ensure product quality.
  • Gather and analyze data, tracking quality assurance metrics for continuous improvement.
  • Collaborate with Engineering on all aspects of production and design processes.
  • Work closely with floor-level staff and various departments to identify and resolve quality issues.
  • Participate in meetings and problem solving with customers as cooperative discussions with a focus on delivering quality outcomes.

Requirements :

  • Bachelor's degree in engineering, Quality Engineering, or a related field (Medical device Mechanical, Industrial, or Manufacturing Engineering preferred).
  • 3-5 years of relevant Quality Engineering experience.
  • Familiarity with quality systems such as ISO 9001, AS9100, or ISO 13485 (ISO 9001 required).
  • Hands-on experience with quality tools such as FMEA, control plans, and root cause analysis techniques (e.g., 5 Whys or Fishbone diagrams).
  • Knowledge of statistical process control (SPC) and quality improvement tools.
  • Experience with validation and verification processes for new equipment or systems.
  • Strong problem-solving and analytical skills, with a focus on continuous improvement.
  • Effective communication and collaboration skills for cross-functional teams.
  • Ability to manage multiple projects and meet deadlines.
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