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Vacancy Details

Quality

Senior Quality Engineer - Limerick

Contract Type: Permanent
Sector:
Location: Limerick
Date: 5/12/2018
Job Reference: 100999
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

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

Senior Quality Engineer

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

Job Description
The Sr. Quality Engineer is accountable for supporting the Research Centre site, Project teams and/or other projects intended to enhance operational effectiveness including the initial creation of a Quality Management System for the site. The Sr. Quality Engineer focuses on the creation of quality processes and procedures at the site which support design control, process control & validation, supplier management and technology transfer based on industry and best practices.
Job Description
The Senior Quality Engineer is accountable for quality support for products developed and process design to achieve these goals through active participation and contribution to multifunctional and multi-divisional teams. The Sr. Quality Engineer is responsible for assuring that quality standards and regulatory compliance activities are consistent with Corporate/Division Policies, Government Regulations, International Standards and standards broadly recognized by the Medical Device Industry.
The position requires a self-motivated, self-directed individual able to handle multiple projects across multiple business units and tasks utilizing a high level of written and oral communication skills. In addition, the incumbent will be expected to initiate quality initiative projects, become thoroughly knowledgeable with all aspects of quality engineering and new product development and assumes personal responsibility for the successful completion of all tasks within the realm of quality engineering responsibilities. The Sr. Quality Engineer reports to the Quality Manager.
Quality Systems development
  • Begin to develop Quality system to support design activities
  • Provides guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
  • Support new product development activities to ensure work follows proper design control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development.
  • Guides the successful completion of major programs and may function in a project leadership role.
SW/HW Development Guidance
  • Help Facilitate Document review and approval with Medication Management System (MMS) BU.
  • Assist with Test Case Reviews.
  • Review and approval of Verification and Validation plans/protocols/reports.
  • Develop Test Method Validation documents.
Risk Management
  • Facilitating and coordinating the risk management process.
  • Responsible for leading the Risk Management Team in determining if new risk management documents will have to be created or if existing product family risk management documents will be updated.
  • Develop the following risk management documents:
o Risk Management Plan
o Risk Analysis
o Risk Management Report
o DFMEA
General Guidance for Project/New Employee Onboarding
  • Accessing C2C training/understanding MMS training requirements
  • Accessing SAP
  • Accessing TFS
  • Accessing Sharepoints
Test Instrument
  • Create Receiving and material handling SOPs
  • Temperature Records Management (e.g. temp charts, OOS, etc.)
  • OOS SOP/Investigation management
Lab Equipment Controls
  • Calibration/PM – Managing, reviewing/approving/OOS investigations
  • Blue Mountain RAM Access/Management (Data entry)
  • IQ/OQ review/approval
  • Liaison with Field Service Engineers to ensure proper documentation of servicing
Technology Development Understanding/Guidance
  • Help project teams understand process and requirements
  • Provides guidance to team and application of Design Controls 21CFR 820.30 for new product development.
  • Creates and supports documentation.

Qualifications:
  • A minimum of 5 years of experience working within a quality function.
  • A minimum of 5 years of experience working in a FDA or ISO regulated environment.
  • A minimum of a bachelor’s degree is required.

Assets:
  • BS Degree in scientific discipline: Engineering, Chemistry, Biochemistry or related science
    Certified Quality Engineering (CQE) preferred.
  • Robust understanding of QSR, Design Control, ISO, Product Risk Management (ISO 14971) and GMPs as defined in CFR 820 and of industry standards but not limited to Green belt and Design for Six Sigma methodology and tools.
  • Excellent people interaction, team building, and communication skills. Problem solving skills with experience in project management to include organization, prioritization, problem solving, and sound judgment are critical. Understanding of statistical analysis expected.
For further information on this Quality Engineer role in Limerick 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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“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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