Associate Quality Engineer

Job Summary:

Associate Quality Engineer is responsible for quality engineering activities for manufacturing processes, materials, and products as well as          within Project Teams. Other activities may be assigned as needed.


 Authority Assignment:

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


 Duties/Responsibilities:

•      Quality Engineering support at Aerogen manufacturing process driving process continuous improvements and providing manufacturing support,          this includes:

o      Process/manufacturing data analysis, trending, and assisting yield reporting.

o      Investigation root cause analysis of quality issues in manufacturing and managing quality related NC’s and CAPA’s. 

o      Address ongoing compliance


•      Timely investigation and analysis of customer complaints identifying any potential trends during failure analysis and initiating improvement                initiatives.

•      Champion continuous process improvement and, in conjunction with other functions, analyse feedback and identify and implement appropriate            problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes.

•      Support of Supplier Quality Control Initiatives as required.

•      Overall responsibility for GMP standards and compliance within Aerogen’s manufacturing area

•      Drive risk management activities in manufacturing (Process FMECA).

•      Manage process quality control system to ensure all manufactured product meets defined specifications prior to shipment.

•      Manage assigned aspects of the quality system in compliance with ISO 13485:2003, 2012. FDA QSR, MHLW and Canadian Quality System               requirements.

•      Conduct internal audits as defined by audit schedules.

•      Quality system training of Aerogen personnel as per defined training plans.

•      Perform other assigned tasks and support all aspects of the Quality System as directed by the Manager.


      Education/Experience:

•     BE/BS Degree.  A Post-graduate qualification in Quality Assurance is preferable although not mandatory.

•     At least one to three years Quality Engineering experience or related role within the medical device industry.


      Specific Requirements:

•      Ability to work on own initiative.

•      Strong team member with the ability to identify and drive implementation of innovative quality improvements.

•      Ability to consistently meet deadlines.

•      Demonstrate and actively promote high levels of professional quality engineering.

•      Good communication skills.  Must have the ability to communicate effectively at all levels of the company.

•      Ability to write clear, concise technical protocols and reports.

•      Good administrative/organizational ability with high level of attention to detail.

•      Ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner.

•      Thorough understanding of ISO 13485:2003, 2012 and FDA QSR.

     Environmental Conditions:

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