Quality Engineer I Trackwise

Actalent•Irvine, CA

32d•$40 - $45•Onsite

About The Position

We are seeking a dedicated Quality Engineer I with proficiency in Trackwise software to join our team. The successful candidate will play a critical role in ensuring compliance with CAPA processes and procedures within the medical device industry. This position requires a detail-oriented professional with a strong understanding of NCR and CAPA processes.

Requirements

Quality engineering experience within the medical device industry.
Proficiency in Trackwise software.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.
In-depth understanding of NCR and CAPA processes.
Knowledge of regulatory requirements for medical devices.

Nice To Haves

Bachelor's degree in Engineering, Quality Management, or a related field.
Minimum of 1-2 years of experience in quality engineering within the medical device industry.
Experience in interacting with regulatory agencies such as FDA, MoH, TUV.
Ability to gain knowledge in supporting Quality Systems.
ASQ Certified Quality Engineer (CQE) or equivalent preferred.
Strong communication and influencing skills.
Ability to manage multiple tasks simultaneously.
Computer literacy, including Microsoft Word, Excel, and PowerPoint.

Responsibilities

Ensure compliance to CAPA processes and procedures.
Review and approve NC and CAPAs, ensuring actions and records are complete, accurate, effective, and timely.
Liaise with relevant functional groups and guide teams through all stages of the NC/CAPA process.
Ensure users maintain a live record with all relevant evidence attached in the eCAPA system.
Facilitate NC and CAPA teams in problem-solving techniques such as human error reduction, 4-D, 5 Why's, fishbone diagrams, and process mapping.
Serve as an eCAPA super-user, proficient in NC/CAPA procedure requirements.
Execute the NC/CAPA review board forums.
Monitor site NC/CAPA KPIs, provide detailed updates, and ensure compliance with global requirements and metrics.
Identify opportunities for continuous improvement and collaboration.
Engage in cross-site and corporate project teams within the NC/CAPA area of expertise.
Coordinate preparation, participation, and follow-up for internal, corporate, and third-party audit activities.