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Vacancy Details

Quality

Senior Quality Systems Engineer - Westmeath

Contract Type: Contract
Sector:
Location: Westmeath
Date: 5/12/2018
Job Reference: 100943
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

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

Senior Quality Systems Engineer

Our client, a medical device company in Westmeath is currently looking to recruit a Senior Quality Systems Engineer for their site.

Description:
The Snr Quality Systems Engineer will act as site SME for Internal Auditing, CAPA, complaint handling and supplier quality. This role will have work closely with the Supplier QE, QA Analyst (Complaints) and QA Analyst (Trending) and provide guidance and assistance as required. Assists in steering quality improvements within the plant working closely with all departments in the implementation of same.

Principal Accountabilities:
  • Act as CAPA Administrator for the site.
  • Assist CAPA champions with documentation associated with CAPA system.
  • Track progress on all CAPAs and escalate all issues to senior management.
  • Host monthly CAB meetings, issue minutes and track action items to closure.
  • Compile data for monthly GBU CAB meetings
  • Liaise with product monitoring in relation to complaints (main plant contact)
  • Ensure that failure investigation is completed in a timely manner in line with plant KPIs.
  • Review and approval of complaints failure investigate reports
  • Work with Design QA and product monitoring with respect to compilation of Health Hazard
  • assessments where applicable.
  • Act as SME with respect to Internal Auditing for the site.
  • Assist the internal audit team with respect to planning/audit reports and corrective action plans.
  • Ensure that internal auditors are trained and proficient with the applicable regulations.
  • Co-ordinate the internal audit schedule and track progress to same on a weekly basis reporting
  • progress and escalating issues to management.
  • Provision of trending and associated metrics for all CAPS, Complaint, Internal Auditing and
  • Supplier Quality KPIs.

Education /Experience
  • A third level qualification in quality or a related discipline. A good understanding ISO 13485, FDA QSRs, JPAL and Canadian Medical Device regulations is desirable for this position in tandem with strong analytical and computer literacy skills.
  • Five or more years’ experience in a quality role (ideally quality systems)
  • Lead auditor qualification preferred, not required.


For further information on this Quality Systems Engineer role in Westmeath 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.
 

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

“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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Clients we are proud to work with

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