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Vacancy Details

Quality

Senior Design Quality Engineer - Roscommon

Contract Type: Permanent
Sector:
Location: Roscommon
Date: 14/04/2017
Job Reference: 86600

Job Description

Contact: Cliona O'Malley
Email: cliona@hero.ie
Telephone: 091730022

Senior Design Quality Engineer

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

Summary of Position:
Provide quality engineering support in design and development of medical device products, specifically ventilators. Facilitate the application of design controls in product development and sustaining changes. Provide support in the rapid resolution of product complaints and/or safety issues.

Essential Functions:
  • Strong familiarity with regulatory requirements (e.g. ISO 13485,CFR 820 & EN ISO 14971)
  • Familiarity with EN ISO 60601-1, EN ISO 60601-1-8, EN ISO 80601-2-12 a distinct advantage.
  • Experience in risk evaluation techniques, e.g. HHE/HHA, Product Risk Assessment, SFMEA/HHA, DFMEA, PFMEA & fault tree analysis.
  • Familiarity with Hardware EE Design & Development: Design Margin, Component Derating, Creep & Clearance, In Circuit Test, IPC, IEC 61000, Design of Experiments & Reliability Analysis.
  • Familiarity with Hardware ME Design & Development: Stack Up and Tolerance Analysis, Key Inspections Analysis Material Analysis, Design of Experiments & Reliability Analysis.
  • ASQ CQE, CRE, CSQE certification desirable, but not essential.
  • Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
  • Ensure design changes to existing products are conducted in compliance with the FDA Quality System Regulations Design phases.
  • Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, con-conflicting and feasible product requirements that support the market needs.
  • Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report). Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report
  • Assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.
  • Provide guidance and direction for sample size and statistical analysis of verification and validation test results. Experience Statistics stools experience an advantage e.g. Minitab.
  • Provide training to project teams on procedures, verification, validation, statistical methods and design controls.
  • Review Design History Files and Technical Files for conformance to applicable requirements.
  • Assist, when appropriate with internal and supplier audits.
  • Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.
  • Support the Regulatory Department in writing technical submissions.
Education / Experience:
  • LEVEL 8 BS with 5 years' experience.
Skills/Qualifications:
  • Strong familiarity with regulatory requirements ISO 13485, CFR 820 & EN ISO 14971.
  • Good verbal and written communication skills including protocol / report development and technical presentations.
  • Risk Management, ISO 14971, FTA, FMEA, HACCP.
  • Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing and ANOVA.
  • Test plan development and root cause failure analysis.


For further information on this Senior Quality Engineer role in Galway please contact Cliona O'Malley on 091730022 / cliona@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

Clients we are proud to work with

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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“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

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“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

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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Clients we are proud to work with

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