Quality Control Engineer

Job Purpose

This position is responsible for QMS and technifinal quality inpection on assigned units, as well as any other duties requested by manager. This position is responsible for QMS and meeting monthly repair targets consistently while adhering to all safety policies and procedures.

Duties and responsibilities:

• Implementation of Quality Management System (QMS) for ISO 13485 design controls in conformance with US FDA Quality System Regulations through the integration of internal and external/medical device industry best practices.
• Ensure that internal activities and external partnerships adhere to applicable regulations and quality standards, including FDA QSR and ISO 9001/ISO 13485.
• Provides CAPA, complaints, audit and overall QMS support.
• Apply quality and regulatory standards to medical equipment and process qualification.
• Interpret internal requirements and write SOP and work instruction.
• Review and approve product design changes and Quality System documentation.
• Manage external partner files and create related Quality System documents.
• Participate in external inspection/audit activities.
• Perform additional duties as assigned by Management.

Education & Experience:

• Bachelor's Degree in Life Sciences, Physical Sciences, Engineering discipline, or equivalent technical field.
• Minimum of 2​-5 + years of experience in Quality Assurance.
• Minimum of 2+ years of experience in the Medical Device manufacturing or pharmaceutical industries.
• Working knowledge of applicable regulations and standards such as FDA QSR and ISO 13485.

Physical requirements:

While performing the duties of this job, the employee is frequently required to stand, walk, use hands to finger, handle or feel objects, use electronic or mechanical repair devices, fine motor skill dexterity, reach with hands and arms, balance, stoop, kneel, crouch, and talk or hear.

The employee may be required to occasionally lift and/or move up to 20 to 30 lbs. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.

Travel:

Occasional. Only as required by business if needed.