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Vacancy Details

Quality

Senior Operations Quality Engineer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 1/11/2018
Job Reference: 93479

Job Description

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

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

Major Accountabilities:
  • Lead and drive QA initiatives within area of functional responsibility.
  • Provide quality input and support to the manufacturing, engineering, prototype and commercial functions.
  • Lead and coordinate preparing & on-going maintenance of FMEAs and Control Plans.
  • Investigating root cause of quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.
  • Strategically lead new product introduction and contract reviews from a QA perspective.
  • Preparing and updating Operations procedures and associated documentation.
  • Overall responsibility for functional area GMP standards and compliance including the promotion of Quality Awareness.
  • Establishing inspection standards, plans, frequencies and test methods.
  • Reporting functional are Quality metrics.
  • Preparation of Quality reports for Operations meetings and management reviews.
  • Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements
  • Develop strong links with customer organisations and other project stakeholders.
  • Understanding of standard metrology good practice.
  • Quality review of functional area validation documentation.
  • Performing and supporting internal and external audits to ISO and FDA requirements.
  • Performing an active role in further development and continuous improvement of the quality management system.
  • Support Operations area projects and initiatives i.e. Kaizen, CFPS etc.
  • Supervision and direction of Quality personnel.
  • Other tasks as directed by the Operations Quality Manager in line with company goals and objectives.

Education:
  • Degree in Science / Engineering or related fields essential.

Requirements:
  • Minimum of 5yrs industry experience in a medical device-manufacturing environment.
  • Clear understanding medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.
  • Strong CAPA experience.
  • Strong root cause analytical and problem solving skills.
  • Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable.
  • New product introduction and manufacturing process transfer experience desirable.
  • Demonstrated excellent organizational skills and ability to work on own initiative essential.
  • Supervisory experience desirable.
  • Excellent written and verbal communication skills essential.

For further information on this Senior Operations Quality Engineer role in Galway please contact Orla 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
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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

Clients we are proud to work with

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