Connecting to LinkedIn...

Vacancy Details

Quality

Quality Engineer - Roscommon

Contract Type: Permanent
Sector:
Location: Roscommon
Date: 18/05/2016
Job Reference: 83171

Job Description

Quality Validation Engineer

Our client located in Roscommon requires a Validation Engineer for their Quality department. This a permanent job but great career opportunities.
The Quality Validation Engineer has responsibility for the effectiveness of assigned areas of the company?s quality system and for completing validations of process and products as required. S/he will also provide validation and manufacturing quality support to the new product introduction manufacturing teams. Championing a structured approach to problem solving and error proofing using 6 sigma and lean principles.

Key Responsibilities:
  • Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with quality system and the requirements of ISO13485, The Medical Device Directive 93/42EEC and FDA Quality System Regulations.
  • Champion the validation system including maintenance and continual improvement of the validation process in line with regulations and industry best practice
  • Provide training and guidance to others on validations as required.
  • Provide support to the NPI engineers and sales to define validation plans and times to meet customer requirements.
  • Provide manufacturing quality engineering support for new product introductions and product changes to improve quality through improved processes and process control.
  • Effective and efficient execution of validation and other projects : Achieve key project deliverables on time and within budget
  • Champion structured approach to problem solving within the organisation using cross-functional teams and six ? sigma methodology.
  • Lead and or participate in CAPA and other cross functional improvement teams to drive manufacturing quality improvements.
  • Project manage and lead cross functional teams with responsibility for the introduction and validation of new processes/ new technology.
  • Work with equipment vendors to mutually understand their and our technical process challenges to improve capability, eliminate cost and improve effectiveness of validations.
  • Assess customer?s validation needs and propose innovative solutions.
  • Maintain validation and other records in accordance with the quality system requirements, which show that products manufactured to meet the requirements of end users, customers, regulatory authorities and the company.
  • Maintain the plants calibration system and equipment calibrations as assigned
  • Investigate, trouble shoot, disposition and report on validation failures, system failures, non-conforming products and other product defects. Champion a structured approach to problem solving within process improvement teams.
  • Identify and implement process controls including SPC as required
  • Investigate, report on, and respond to customer complaints as assigned

Education, Experience and Skills:
  • A degree in engineering or equivalent with 2/ 3 years medical device/pharmaceutical and/or diagnostics manufacturing experience including
  • A good working knowledge of ISO13485, FDA Quality System Regulations.
  • Self-starter with good inter-personal skills. Ability to multi-task is essential.
  • Have an ability to work hands-on, with a solid engineering background, engaging cross-functional groups, equipment and material vendors to resolve technical issues.


For further information on this Quality Validation Engineer role in Roscommon 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

W1siziisijiwmtyvmduvmdgvmtivmtkvmdevndq5l2fiynkucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmtkvntuvnze4l2fszxjllnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjavmtevmtewl2fsa2vybwvzlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjavndavmje4l2jvc3rvbi5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjavntivotayl2nhbwj1cy5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjevmdcvmze0l2nlbgvzdgljys5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjevmtkvnjcxl2noywvsbguucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjevmzqvote3l2nvy2fjb2xhlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjevndgvnzm1l2nyzwdhbmeucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjivmdmvoti1l2dvb2rtyw4ucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjivmtgvodewl2phbmrqlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjivmzivmtcwl0pmtc5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjivndcvnde3l2xpbgx5lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjivntkvnjeyl21hcmluzs5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjmvmtcvntqzl21lzhryb25pyy5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjmvmzavote4l21lcml0lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjmvndqvodexl211c2dyyxzllnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmdavmja5l3blbm4ucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjqvmtivnjg5l3bpdm90lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmjyvmzuxl3byb3h5lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmzgvmtm0l3j1c2fslnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvntmvoty1l3nhbm1pbmeucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjuvmdyvnza4l3n0zxjpcgfrlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjuvmjmvmjgwl3n0cnlrzxiucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjuvndqvota2l3rozxjtb2xpbmcucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmtivmdyvmtivntgvmjcvnze0l3ntdc5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
More

“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
More

“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
More

Clients we are proud to work with

W1siziisijiwmtyvmduvmdgvmtivmtkvmdevndq5l2fiynkucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmtkvntuvnze4l2fszxjllnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjavmtevmtewl2fsa2vybwvzlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjavndavmje4l2jvc3rvbi5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjavntivotayl2nhbwj1cy5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjevmdcvmze0l2nlbgvzdgljys5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjevmtkvnjcxl2noywvsbguucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjevmzqvote3l2nvy2fjb2xhlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjevndgvnzm1l2nyzwdhbmeucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjivmdmvoti1l2dvb2rtyw4ucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjivmtgvodewl2phbmrqlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjivmzivmtcwl0pmtc5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjivndcvnde3l2xpbgx5lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjivntkvnjeyl21hcmluzs5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjmvmtcvntqzl21lzhryb25pyy5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjmvmzavote4l21lcml0lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjmvndqvodexl211c2dyyxzllnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmdavmja5l3blbm4ucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjqvmtivnjg5l3bpdm90lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmjyvmzuxl3byb3h5lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmzgvmtm0l3j1c2fslnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvntmvoty1l3nhbm1pbmeucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjuvmdyvnza4l3n0zxjpcgfrlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjuvmjmvmjgwl3n0cnlrzxiucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjuvndqvota2l3rozxjtb2xpbmcucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmtivmdyvmtivntgvmjcvnze0l3ntdc5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
More