Quality Engineer

Job Responsibilities:

* Create quality inspection plans and work instructions for incoming, in-process, and outgoing parts to ensure components meet specifications.

* Define training plans; train QC Supervisors, Technicians, and Inspectors on dimensional and functional inspection processes.

* Perform First Article Inspection for new materials and parts.

* Execute qualification and validation of equipment, processes, and test methods.

* Ensure inspection equipment complies with calibration and preventive maintenance requirements.

* Participate in PFMEA activities to address and mitigate manufacturing risks.

* Handle complaint investigations, identify root causes, and implement CAPA actions.

* Manage non-conformances, perform disposition of rejects, trend yields, identify causes, and execute corrective actions.

* Work in controlled manufacturing environments (e.g., clean-room) with proper gowning procedures.

* Initiate or execute engineering changes per Engineering Change Control procedures.

* Participate in internal and external audits to support quality system effectiveness.

* Take part in continuous improvement programs such as 6S and yield improvement.

* Support new product introduction projects from a quality standpoint.

* Perform other tasks as assigned by the supervisor.

Requirements:

* Work experience as a Quality Engineer in a medical device manufacturing environment.

* Diploma or Degree in Engineering, Science, or related fields (Diploma holders may be considered for Assistant Quality Engineer; experienced candidates may be considered for Senior Quality Engineer).

* Experience in qualification/validation of equipment, processes, and test methods for new product introduction.