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Vacancy Details

Quality

Senior Quality Engineer - Kildare

Contract Type: Permanent
Sector:
Location: Kildare
Date: 1/09/2017
Job Reference: 89018

Job Description

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

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


Position Summary/Scope:
  • Reporting to the site General manger, this position has site wide oversight for the Quality Management System including the role of Management Representative for any FDA manufacturing and inspections
  • The incumbent will be a subject matter expert (SME) for medical device manufacturing and provide oversight and expertise to all Medical Device related quality policies and procedures.
  • The incumbent will lead regulatory discussions and audits with potential new customers in Medical Device segment and external quality/regulatory groups where applicable.
  • In operational Medical Device business, this Role will support escalations and provide input and expertise.
Key Responsibilities:
  • Authority to escalate any significant quality non-conformances event above site management to corporate regulatory authority
  • Monitors site performance to ensure ongoing conformance to the Quality Management System
  • Site EN ISO 13485:2012 SME and lead upgrade to 2016 standard.
  • Provide expertise input and approvals to Master Validation Plans for each Business Unit
  • Lead audits from external regulatory agencies (FDA, HPRA, ANVISA, PMDA) and customers and leads preparation activities in advance of such audits.
  • Ownership of the sites Medical Device quality policies and procedures.
  • Oversight and final approver for critical activities such as CAPA, Change Control, Risk Assessment, Design, Validation, Control Plan reviews
  • Provide training as required on quality systems, audit, eDMS and data analysis tools.
  • Creates and evaluates metrics to drive the quality improvement process.
  • SME for appropriate statistical techniques to monitor process performance (e.g. SPC, Cpk, R&R analysis, sampling techniques).
Core Knowledge/Skills/Competencies:
  • In-depth knowledge of 21 CFR parts 807, 820, 803, EN ISO 13485:2012. Knowledge of the Pharmaceutical regulations including 21 CFR 200-211 is desirable.
  • Excellent customer contact, negotiation and problem resolution skills.
  • Experience in the use of techniques such as Design of Experiments, Gauge R&R, Test Method Validation, sample size justification to support design changes, validations, deviations are required.
  • Excellent interpersonal, written, and verbal communication skills.
  • Ability to effectively communicate & collaborate with a wide variety of internal and external customers.
  • Works well on a team with proven ability in building excellent cross functional relationships
  • Ability to evaluate materials, gather and analyse data and determine root cause of problems.
  • Strong Project Management skills & ability to manage several projects simultaneously and coordinate multiple, changing deadlines.
Typical Experience/Education:
  • Min of 9-15 years' experience in a Quality Engineering role in Medical device manufacturing - essential
  • Min of 4 FDA inspections as the Quality Manager.
  • Degree qualification minimum in a related field - essential
  • Lead Auditor conducting Quality Audits essential, with experience of FDA/HPRA audits highly desirable
  • Experience of 6 Sigma methodology. Ideally a 6 sigma black belt.
  • Project Management Training/Experience - an advantage

For further information on this Senior Quality Engineer role in Kildare please contact 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

“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
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“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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