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Vacancy Details

Quality

Senior Design Quality Engineer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 1/08/2017
Job Reference: 79127

Job Description


Senior Design Quality Engineer

Our client, a medical device company in Galway is currently looking to recruit a Senior Design Quality Engineer for a permanent job.

Key Responsibilities:

  • 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.
  • Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
  • Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations.
  • Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous 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).
  • Partner with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews occur, and to demonstrate software capability and maturity.
  • 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.
  • Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
  • Provide training to project teams on procedures, verification, validation, statistical methods and design controls.
  • Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report
  • Review Design History Files and Technical Files for conformance to applicable requirements
  • Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.

Education, Experience and skills

  • Minimum Level 8 Honours Degree in Science or Engineering with 5-8 years
  • Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.
  • Risk Management, ISO 14971, FTA, FMEA, HACCP.
  • Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.
  • Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis.
  • Test plan development and root cause failure analysis.
  • Preferred Skills/Competencies: Previous experience working in a cross-functional team environment.
  • ASQ CQE, CQA, CSQE and/or CRE certification.
  • Familiar with statistical software tools (Minitab, Stat Graphics, Statistical),
  • Stability, Biocompatibility, Sterilization, Ship Testing, HALT/HASS.
  • Familiar with IEC 60601 and product specific industry standards.
  • Familiar with DMAIC or DMADV(DFSS) methodologies
  • DFSS / Lean Green Belt or Black Belt


For further information on this Senior Design Quality Engineer role in Galway please contact Cliona O'Malley on 091730022 / cliona@ccprecruit.ie
Check out all our open jobs on our CCP Recruitment website - www.ccprecruit.ie

Please Note: CCP 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,
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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”. 

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“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,
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“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”.

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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

“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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