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Vacancy Details

Quality

Principal Quality Engineer (Microbiologist) - Wexford

Contract Type: Permanent
Sector:
Location: Wexford
Date: 28/11/2018
Job Reference: 99997
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

Contact: Bimi Felix
Email: recruit@hero.ie
Telephone: 086 8395533

Principal Quality Engineer (Microbiologist)

Our client, a medical device company in Galway is currently looking to recruit a Principle Quality Engineer for their site.

Accountabilities include:
The Principal Quality Engineer is responsible for:
  • The co-ordination and control of sterilisation, biocompatibility (finished product and raw materials) and environmental monitoring (including all cleanrooms)
  • Responsible for the training of the quality inspectors in relation to sterile release and for overseeing this approval.
  • Playing a role in the plant annual objectives.
  • Ensure continued compliance with all Regulatory Standards. These includes:
    • ISO 11135
    • ISO 10993
    • ISO 14644
    • ISO 14698
    • ISO 11607
    • ISO 13485
    • FDA QSR
    • ISO 14000
    • Ensuring continued compliance with DMR
  • Monitor all aspects of product and paperwork preparation for sterilisation and approval and environmental monitoring in the manufacturing process for compliance to ensure quality product is shipped to customer and provide:
    • Trend analysis of data
    • Potential improvements for review based on the trends.
    • Areas for improvement to senior management.
    • Review and propose changes to sampling plans based on trend analysis and
changes to the system.
  • Ensuring continuous compliance with the following:
    • Related sterilisation validation standards.
    • Related biocompatibility and environmental standards
  • Conduct training in sterilisation and microbiological and related procedures as required.
  • Drive the site validation for sterilisation, including all liaisons with the contract steriliser.
  • Interacting and presenting sterilisation and microbiological documentation during FDA, NSAI, Corporate and customer audits.
  • Carry out a documented monthly evaluation of cleanrooms
  • Support any RCA meetings related to sterilisation and /or environmental monitoring to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
  • Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner
    • Sterilisation and cleanroom Validations.
    • Product adoptions to the LRI sterile cycle
    • Engineering Change Order (ECO).
    • Request for Corrective Action (RCA).
    • Request for Technical assistance (RTA)
    • Material Review Request (MRR) – must countersign all related to sterilisation and environmental monitoring.
    • Internal Audits.
    • Failure Mode Effect Analysis (FMEA).
    • Variation Permits (VP).
  • Work on specialised projects as required.
  • Ensure the company behavioural standards are adhered to, setting the example yourself for your direct reports.
  • Project meeting attendance as required.
  • Attend and participate in daily cell meetings.
  • Preparation of information for PMR and Management Review meetings.
  • Ensure that in your absence (or absence of any of your reports) your department provides adequate day to day service. Ensure that other departments know of your arrangements well in advance.
  • Ensuring backup and notification for any absences within the group, and being able to step down when required based on priorities.
  • Work efficiently using own initiative, escalating decisions as, when, and only when, necessary.
  • Be an active member of the team and work with all employees to develop a world class lean manufacturing system.
  • Ensure the company behavioural standards are adhered to.

SKILLS AND KNOWLEDGE:
  • Ability to communicate and work with people inside and outside the department.
  • Good communicator (written and oral).
  • Ability to train and lead where required.
  • Ability to co-ordinate, plan and organise in a timely manner.
  • Knowledge of engineering theories and methods, demonstrating an aptitude for analysis and problem solving.
  • Rigorous attention to detail.
  • Ability to work independently and without direct supervision while maintaining adherence to timelines is fundamental to the role.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:
  • Engineering or science Degree.
  • Qualification in microbiology is preferable
  • A Six Sigma qualification will be a distinct advantage.
  • Good PC skills
  • 1-3 years’ experience in a quality assurance role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment

PHYSICAL & MENTAL DEMANDS.
  • Dealing with Ambiguity.
  • Work effectively with close tolerances.
  • Conflict Management
  • Timely Decision Making


For further information on this Q E role in Galway please contact Bimi on 086 8395533 / recruit@hero.ie

Check out all our open jobs on our HERO Recruitment website – 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.

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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”. 

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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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“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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