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Vacancy Details

Engineering & Technical

Senior Global Quality Systems Engineer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 1/09/2017
Job Reference: 88930

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 091730022

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


Primary Role:
  • The Snr. Global Quality Systems Engineer is a member of the Global Quality Systems department with primary responsibility for support of the QMS in Central America
  • Their primary responsibilities are:
  • Enhancement of the Quality Systems across the two Central American sites, in support of global quality system activities. Working to develop and manage quality system requirements while coordinating the implementation of these requirements across multiple sites. The individual shall possess skills in FDA (QSR) and ISO 13485 quality systems in a medical device manufacturing environment.
  • The Snr Global Quality Systems Engineer may also from time to time assume other Snr Quality Engineering or Quality Management responsibilities relating to areas such as product disposition, Complaints, training - as deemed appropriate and based on experience and training.


Qualifications:
Key Responsibilities:
  • Develop and implement world-class Quality System processes in support of the business requirements, working closely with site Quality leaders.
  • As a site matures (such as moving from component manufacturing to Finished Device manufacturing) lead the development of the site quality system to meet the additional requirements.
  • Ensure all aspects of the sites QMS (Management Reviews, Internal Audits, and Supplier Management etc.) are in compliance with the global quality procedures.
  • Represent Quality in customer meetings; represent the Global Quality organization and be able to outline the company Quality system and principals as part of business proposals, QBRs etc.
  • Responsible for scheduling, planning, conducting, communicating and reporting on global internal audit results.
  • Liaise closely with the Project Management Office to be aware of NPI/transfers into the sites that could impact the QMS, and plan for such changes.
  • Support implementation of Electronic Quality Systems and other systems that could impact the QMS.
  • Serves as Quality Approver on Engineering Change Orders (ECOs)/Document Change Orders (DCOs), Training Matrices, and other documents as requested.
  • Facilitate improvement teams for quality systems. Provide recommendations to consolidate, standardize, simplify, and establish systems that are compliant with ISO, FDA (QSR), and customer requirements.
  • Ensure applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/ modifications related to relevant standards and regulations.
  • Evaluate business goals, identify improvement opportunities and apply scientific methods, statistics and problem solving techniques where appropriate to improve and sustain quality system effectiveness.
  • Plan and execute projects and team activities to facilitate quality system changes.
  • Create and revise quality system documentation.
  • Act as Lead Auditor to evaluate compliance with corporate policies, site procedures and other applicable regulatory requirements.
  • Responsible for scheduling, planning, conducting, communicating and reporting on corporate internal audit results.
  • Support external audits as needed, which may include assisting with prep activities, conducting mock audits, supporting front room and back room activities, and preparing responses.
  • Supports change management and organizational strategy across the sites
  • Lead/participate on projects which directly support compliance and/or continuous improvement of site(s), departmental and global processes.
  • Develop solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
  • Perform site trainings (GDP, GMP, CAPA, Compliance, etc.)
  • Thoroughly understand the quality system process to negotiate and challenge the investigations & root-cause results, proposed actions, and effectiveness plans to ensure the true root-cause is addressed
  • Maintains strong knowledge of CAPA system and procedures, drives CAPA Compliance & provides CAPA oversight.
  • Adhere to company code of conduct, policies and practices.
  • Demonstrate computer skills with Microsoft Office (Word, Excel, PowerPoint, and Visio).
  • Calculate and present KPI metrics at internal meetings as required.

Key Competencies (Education/Skills/Experience):
  • Degree in Engineering or Science.
  • Post graduate qualification in Quality or at least 5 years' experience in a Quality Systems Engineering role.
  • Strong compliance, process and audit experience. Proficient problem solving and investigation skills
  • Manage multiple tasks and accomplish them in a timely manner
  • Ability to work on own initiative with remote management.
  • Trained lead auditor with experience in performing quality system audits.
  • Excellent "hands-on" technical skills.
  • Excellent communication and inter-personal skills.
  • Highly organized with strong ability to prioritize tasks and work on own initiative.
  • Ability to evaluate information gathered from observation, experience, reasoning, and/or communication, Demonstrated clarity, accuracy, precision, independent judgment and thoroughness
  • Strong knowledge of ISO and FDA quality requirements.
  • Excellent attention to detail and report writing skills.
  • Have willingness to travel up to 20% of time.

Bimi Felix on 091730022 / bimi@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

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“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

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“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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