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Vacancy Details

Quality

Senior Quality Assurance Engineer - Westmeath

Contract Type: Permanent
Sector:
Location: Westmeath
Date: 5/11/2018
Job Reference: 100119

Job Description

Contact: Orla Crowley Healy
Email: Talent@hero.ie
Telephone: 086 0449473

Senior Quality Assurance Engineer Westmeath

Purpose of Job:
Responsible for: Providing Quality support to processes, materials, and products. Assuring Quality standards are maintained and assist with the implementation of and compliance to the Quality Management program and for supporting company goals, objectives, policies, procedures, quality systems and compliance with regulatory requirements (ISO, FDA, JPAL and other agencies as applicable).

Responsibilities:
  • Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instruction updates, and FMEA’s for any product line extensions, process improvements for new and existing products.
  • Review and/or develop and execute facility, software, process and equipment validations and risk management documents.
  • Review change controls for validation impact.
  • Use knowledge of statistics to assist with validation developments and process improvements
  • Provide quality support to Manufacturing Engineering with sampling plans, data processing or analysis for validation for new and existing product lines.
  • Assist in the analysis and resolution of problems that may reduce the efficient running of production lines.
  • Provide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.
  • Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
  • Perform Internal Audits.
  • Assist in the development, analysis and improvement of site Quality Metrics.
  • Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
  • Will comply with all relevant training required and adhere to relevant associated documentation.
  • Follow strict adherence to the requirements of CGMP.
  • Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
  • Act as a Mentor in developing and training staff within the Quality department.
  • Is an influential team member, fully motivated to achieve and demonstrate best practices in line with the site strategic objectives?
  • Drives changes in procedures and standards to facilitate work efficiency and to maintain quality.
  • Active management within Project Teams to identify quality requirements.

Requirements:
  • Degree in Engineering or Science or minimum 5 years’ experience in a Medical Device environment.
  • 5 years’ experience working in a regulated environment, specifically medical device, FDA or ISO 13485 registered work environments.
  • Strong computer skills (MS Excel, PowerPoint, Word etc.)
  • Familiarity with statistical tools such as Pareto charts and trend charts.
  • Familiarity with FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.
  • Experience with problem solving techniques
  • Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.

For further information on this Senior Quality Assurance Engineer role in Athlone please contact Orla Crowley Healy on 086 0449473/ Talent@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

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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
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

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