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Vacancy Details

Quality

Quality Engineer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 6/04/2018
Job Reference: 93718

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 086 8395533

Quality Engineer

Our client, a medical device company in Galway are currently looking to recruit a Quality Engineer for their site.

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:
  • 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 the company’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 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 three to five 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.

For further information on this Quality Engineer role in Galway please contact Bimi Felix on 086 8395533 / bimi@hero.ie

Check out all our open jobs on our HERO Recruitment website – www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval

 

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Moira Faherty,
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Chanelle Group

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Adrian Rice,
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“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

“Merit Medical have partnered with Hero for the past 10 years. During this time we have grown our employee numbers to 630 employees. Our experience of working with HERO is that they have a personal client focused approach, they know the market and they can deliver on the candidates.  The medical device market is competitive and our company success is dependent on the quality of our people, we want the best there is in the market so we can grow and in turn offer development opportunities to our people. 

Mary Collins,
Senior Director, Human Resources Europe
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Lorraine McDonnell,
Senior Talent Acquisition Specialist
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