Quality Technician – Manufacturing (Evening Shift)

Job Summary:

Work closely with the Quality Engineering team and specifically on the evening 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

Duties/Responsibilities:
The position requires the person to take the lead or perform tasks in the following areas of Quality:
•  MRB (Materials Review Board) system and material control
•  Incoming Inspection system and process, completing inspections and processing supplier receipts.
•  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 including in process and final inspections.
•  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 2/3 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.