Connecting to LinkedIn...

Vacancy Details

Quality

Associate QA/RA Specialist - Galway

Contract Type: Contract
Sector:
Location: Galway
Date: 12/10/2016
Job Reference: 85312

Job Description

Associate QA/RA Specialist

Our client, a medical device company in Galway are currently looking to recruit an Associate QA/RA Specialist for their site.

Description
  • Participates in the company's medical device and/or drug surveillance platform; including the intake, evaluation, processing, and follow-up on product performance events, complaints, and adverse reports. The MDR Specialist analyses events reported from multiple inputs on coronary and peripheral vascular products to determine complaint status and regulatory reportability. In addition, this position supports the on-going monitoring of product performance.
  • Works cross-functionally to ensure maintenance and review of events and complaints, reporting of Medical Device Reports (MDRs), ADE data, or adverse reaction data, as set forth by the FDA and other regulatory agencies. Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information. Supports and represents complaint handling in internal and external audits and inspections.
  • As part of the Cardiac and Vascular Group Product Experience Management organization, we seek candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action.

POSITION RESPONSIBILITIES:
  • Electronically process events to determine complaint and reportability status.
  • Open track and maintain records for complaint events received.
  • Complete applicable Medical Device Reports (MDR) as required per internal policy & procedures and FDA regulations.
  • Ensure complaint investigations are adequate, accurate, detailed and timely.
  • Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.
  • Collaborate with appropriate technical, Clinical, Field/Sales and/or returned product analysis employees to determine reporting eligibility.
  • Complete electronic submission of MDRs to the FDA.
  • Ensure accurate data entry, scanning, and retention of documents to complete event files.
  • Support internal systems, methods, and procedures to maintain compliance.
  • Develop and maintain product knowledge of CRHF products.

Experience and Qualifications
  • Bachelor?s Degree in an Engineering or Science discipline
  • At least one year experience in a health, clinical, technical, or scientific field
  • Can work independently in a team environment
  • Attention to detail
  • Strong communication skills



For further information on this Associate QA/RA Specialist role in Galway please contact Jenny Dore on 0212066287 / jenny@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