Katalyst Healthcares and Life Sciences
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.
- ssist 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.
- 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.
- bility to manage multiple projects and meet deadlines.