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Vacancy Details

Quality

Senior Biocompatibility Engineer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 11/11/2016
Job Reference: 82574
Contact Name: Nicola O'connell
Contact Email: nicola@hero.ie

Job Description

Senior Biocompatibility Engineer

Our client, a medical device company in Galway are currently looking to recruit a Senior Biocompatibility Engineer for their site.

Duties & Responsibilities:
  • Functioning effectively as a quality engineering extended product development project team member as part of a wider cross functional team, developing strong partnering relationships with these groups, at both the manufacturing and design sites, with a focus on biocompatibility validation and chemical characterization.
  • Working with the team to design protocols to ensure that new products/ product changes are adequately evaluated/tested with respect to biological requirements to guarantee compliance to all regulatory standards.
  • Support the characterization and biological risk assessment of manufacturing process changes, packaging changes and supplier changes.
  • Lead process and method development activities and drive continuous improvement in day-to-day activity.
  • Use and establish analysis techniques and other quality control tools to aid decision - making.
  • Keep abreast of industry best practice with respect to evaluations and laboratory test methods/techniques.
  • Liaise with other departments, sites, functions and vendors on a frequent basis.
  • Liaising with test laboratories to issue test details for testing required and to receive test results.
  • Ensuring that all required testing is completed in a timely manner and reports approved to meet project timelines.
  • Supporting the Regulatory Affairs department in preparing submissions to notified bodies and addressing any questions regarding these submissions.
  • Reviewing all applicable regulatory standards to ensure that requirements are reflected in internal documentation and implementing changes when standards are revised.
  • Performing quality audits of external contactors and supporting audits performed by internal auditors or notified bodies.
  • Manage, motivate and develop personnel within the department to achieve departmental and organizational goals.

Qualifications
  • Minimum of a Bachelor's degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science).
  • 5-8 years' experience in a medical devices or related environment with direct experience in a QA environment (GMP regulated).
  • A good working knowledge of chemistry/biocompatibility validation is desirable.
  • Excellent verbal and written communication skills are essential for this role
  • The ability to work alone or as part of a team.
  • The ability to utilize a driven approach to problem solving.
  • Experience in a related area is an advantage.

Desired Competencies:
  • Executes: Takes accountability for and delivers consistent decisions, actions, and results. Aligns team, allowing people to move quickly in a coordinated fashion
  • Clear Thinking: Translates complexity into simplicity and articulates crisply and clearly, Creates and communicates a clear strategy/plan, Demonstrates good judgment
  • Driven To Win: Passionate and driven, Makes tough decisions in difficult situations, Capacity for work
  • Compliance & Integrity: Promotes and practices a culture of integrity, ethics and compliance with laws and policies. Champions implementation of compliance policies, training and monitoring programs. Expeditiously takes appropriate actions when problems occur.

For further information on this Senior Biocompatibility Engineer role in Galway please contact Nicola O'Connell on 091730022 / nicola@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,
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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