Quality Engineer

Job Summary:  


Quality Engineer is responsible for leading project and supplier improvement activities for the quality engineering department.  Other activities may be assigned as needed.



Duties/Responsibilities:   


•Lead Quality Engineering support at Aerogen on project activities i.e.: Design Improvements, Supplier Transfer’s, Cost Improvements, and New Product Introductions etc.

•Manage activities within the project teams ensuring that project planning is completed correctly with full evaluation and engagement from the necessary resources.

•Lead investigation of component/material quality issues should they arise during projects - work with quality, materials, manufacturing and suppliers to resolve issues.

•Manage Product and Process Validation activities with Suppliers.

•Support the selection, development, and management of new Suppliers to ensure Aerogen Supplier Approval Requirements are met.

•Establish analysis techniques and other quality control tools within project activities as well as utilization of these to solve specific supplier quality problems. 

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

•Overall responsibility for GMP standards and compliance within Aerogen’s Project Teams and Supplier Engagement.

•Completion of relevant NC/CAPA actions and support of Customer Complaint Process as identified.

•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: 


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

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


Specific Requirements:


•Ability to work on own initiative.

•Injection Moulding Experience desirable.

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

•Ability to work within project teams, consistently meeting deadlines and ensuring that all actions are being addressed appropriately.

•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 and with suppliers.

•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 and FDA QSR standards.


Environmental Conditions:


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