Quality Engineer

Location

Galway - Ireland

Department Name

Quality Assurances/Regulatory Affairs (QA/RA).

Functional area

QA/RA

Reports To

Senior Quality Engineer

Job Summary

Quality Engineer is responsible for leading quality engineering activities for manufacturing processes, materials, and products. Other activities may be assigned as needed.

Duties / Responsibilities

  • Lead Quality Engineering support at Aerogen manufacturing process driving process continuous improvements and providing manufacturing support, this includes:
    • Process/manufacturing data analysis, trending, and assisting yield reporting.
    • Investigation root cause analysis of quality issues in manufacturing and managing quality related NC’s and CAPA’s.
    • Establish analysis techniques and other quality control tools such as SPC, Cpk, Ppk.
    • Lead the Materials Review Board (MRB) process.
    • Address ongoing compliance
  • 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.
  • Establish inspection plans, frequencies and test methods for incoming material/parts.
  • 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.

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.

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.

Closing Date for Application

Closing Date:  3rd April 2017

Aerogen is the world’s leading medical device company specialising in the design, manufacture and commercialisation of aerosol drug delivery systems. 

Founded in Galway, Ireland in 1997, we have grown to become the global leader in high performance aerosol drug delivery, partnering our technology with the leading mechanical ventilation companies. 

Aerogen technology is used by millions of patients and caregivers in over 75 countries worldwide.

To find out more go to www.aerogen.com

 

Some of the benefits our employees enjoy at Aerogen: 

  • VHI including Dental
  • Pension
  • Bonus
  • DIS
  • PHI
  • On-site Free Parking
  • Paid Holidays
  • Sports & Social Club
  • Flexi- Start Time.