Quality Technician - Manufacturing (Night Shift)

Job Summary

Work closely with the Quality Engineering team and specifically on the night shift provide front line quality support to ensure all manufacturing process, materials and products are supported from a quality and compliance perspective. Lead improvement activities within these areas to ensure all systems and processes are efficient and effective. Other activities may be assigned as needed.


Authority Assignment:

During periods of absence, the Snr Quality Engineer shall ensure that all the responsibilities of this position are appropriately assigned. The Snr Quality Engineer has the authority to act on behalf of the Quality Technician.


Duties/Responsibilities:

The position requires the person to take the lead in the following areas of Quality:

• MRB (Materials Review Board) system and material control

• Incoming Inspection system and process.

• Support of Manufacturing process changes and improvements including Quality Inspection at different points in the process.

• Process Quality control to ensure all product meets its requirements prior to shipment 

• Corrective Action activities related to manufacturing process and systems and NC/CAPA system.

• Identifying any potential trends during failure analysis and initiating improvement initiatives

• Trending and reporting on the Key Quality and Performance Objectives for manufacturing quality

• Maintain compliance with ISO and FDA Quality System regulations

• The role will also support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary.         The role will require a high degree of flexibility to coordinate the variety of tasks.


Education/Experience:

• A minimum of a certificate in a Quality/Science or related discipline and at least 3 years practical and relevant experience working in a Medical Device Operations environment.


Specific Requirements:

• A "self starter" in terms of time and task management and operate with minimal supervision

• Strong problem solving ability

• Good communicator both verbally and in writing with ability to influence

• Ability to meet deadlines.

• Good understanding of ISO 13485 and FDA QSR quality standards.

• Proficiency in use of desktop software applications such as MS Office


Environmental Conditions:

• Typical office environments, with work also performed in R&D and manufacturing labs, and customer/supplier locations.