Job Title: Quality Engineer
Location: Camden, NJ
Employment Type: Full-Time
We are looking for a detail-oriented and proactive Quality Engineer to join our team. In this role, you will play a key part in ensuring product and process excellence by coordinating quality assurance efforts, managing FMEAs and control plans, and collaborating with cross-functional teams.
Responsibilities:
- Develop, review, and manage production Failure Mode Effects Analysis (FMEA) and control plans.
- Investigate quality issues, identify root causes, and implement corrective and preventive action plans.
- Support the validation and verification of new equipment and processes.
- Design, develop, and execute manual and automated tests to ensure product quality.
- Analyze data and track quality assurance metrics to drive continuous improvement.
- Collaborate with engineering teams on production and design processes.
- Work with floor-level staff and departments to resolve quality concerns.
- Participate in customer meetings and problem-solving discussions focused on delivering quality outcomes.
Qualifications:
- Bachelor’s degree in Engineering, Quality Engineering, or a related field (Medical Device, Mechanical, Industrial, or Manufacturing Engineering preferred).
- 3-5 years of Quality Engineering experience.
- Familiarity with quality systems such as ISO 9001 (required), AS9100, or ISO 13485.
- Hands-on experience with FMEA, control plans, and root cause analysis tools (e.g., 5 Whys, 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.
- Excellent communication and collaboration skills.
- Ability to manage multiple projects and meet deadlines.
