Connecting to LinkedIn...

Vacancy Details

Quality

Biocompatibility & Sterilisation Engineer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 23/07/2020
Job Reference: 107364
Contact Name: Clara Burke
Contact Email: science@hero.ie

Job Description

Biocompatibility & Sterilisation Engineer

Job Summary
Works with Operations, R&D and/or external customers to plan and execute identified Biocompatibility and Sterilisation activities. Supports key programs such as Biocompatibility assessments, sterilization validation and environmental monitoring. Responsible to monitor and implement changes to respective programs as improvements or updates are identified.

Duties/Responsibilities
  • Site SME for all Biocompatability activities, providing technical excellence in the field and selection of testing strategies and materials.
  • Develop Sterilisation plans for products as required and Lead sterilisation validation for new products and related change control.
  • Ensure compliance to all relevant regulations for sterilisation and microbiology which includes maintaining all quality systems and related documentation.
  • Collaboratively work with external contract sterilization test facility and contract testing services.
  • Support Operations and R&D Project Teams with respect to Biocompatability testing strategies and sterilization validation requirements.
  • Management of process deviations, NCRs and CAPAs related to Biocompatability & Sterilisation Processes.
  • Knowledgeable of the associated Quality System requirements and interpretation of same ISO/FDA/AAMI related to biocompatibility and sterilisation.
  • Conduct supplier auditing as required as SME for sterilisation.
  • Management of the site environmental monitoring program.
  • Support external audits including notified body and FDA audits.
  • Promote the awareness of regulatory and customer requirements throughout the organization.
Education/Experience
  • Level 8 Degree in Science/Engineering.
  • Minimum of 5 year's experience in a quality engineering / sterilisation / microbiology role, preferably in the Medical Device sector.
  • Familiarity with regulations and standards published by FDA, USP, AAMI, ANSI, ASTM, and ISO in the areas of biocompatibility & sterilisation.
  • Knowledge of Microbiological and Environmental monitoring programs preferred.
  • Supplier/Internal Auditing experience.
  • Excellent planning and coordination skills plus verbal and written communication skills.

Specific Requirements
  • Ability to work within a team environment to achieve agreed company goals.
  • Ability to communicate effectively with all levels of the company.
  • Ability to meet deadlines and follow through on assigned deliverables.
  • Good understanding of ISO 13485 and FDA QSR quality standards.
  • Attention to detail.
  • Proficiency in use of desktop software applications such as MS Office
For further information on this Quality Engineer (Biocompatibility & Sterilisation) role in Galway please contact Clara Burke on 086-8168273 or email science@hero.ie
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie

Please Note: Under its obligation under the Data Protection legislation, 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

"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

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

Nikhil Pradeepkumar
Optical Engineer
Valeo Vision Systems
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

"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

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

Nikhil Pradeepkumar
Optical Engineer
Valeo Vision Systems
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