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Vacancy Details

Engineering & Technical

Quality Assurance Manager - Offaly

Contract Type: Permanent
Sector:
Location: Offaly
Date: 21/05/2018
Job Reference: 95158

Job Description

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

Quality Assurance Manager

Our client, a medical device company in Tullamore is currently looking to recruit a Quality Assurance Manager for their site.

Essential Duties and Responsibilities
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
  • Ensure that all aspects of the operational business in the site comply with cGMP legal and regulatory requirements as well as Group Quality Manual and Policies.
  • Provides direction, management support and leadership for QA/FDA remediation plans to insure compliance with FDA, QSR, ISO 13485, Corporate Policies and other quality system requirements.
  • Ensure that compliance and quality risks are understood and are always integral part of business decisions.
  • Establish and follow QA training program for the whole site.
  • Support and supervise QA upgrade projects, harmonisation and ensure compliance with current standards.
  • Implement a supplier QA program for the suppliers and sub-contractors associated with the products, including performing & co-ordination of supplier audits.
  • Manage, support and supervise quality projects and ensure that quality problems and technical matters are resolved consistent with global standards.
  • Liaises with Operations, PD, and others departments to prospectively plan QA support for project milestones.
  • Organize and conduct external Inspections (FDA, Corporate) and follow their remediation plan.
  • Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.
  • Proactive, analytical and predictive mind-set to
  • Ensure timely and complete site reporting, including relevant KPI and indicators.
  • Drive continuous improvement and efficiency initiatives in Quality operations.
  • Carry out other tasks or responsibilities as directed, to continuously improve Quality Assurance within the Company.
  • Manage QA budgets.
  • Revision of existing product documentation as required.
  • Create Technical Bulletins, Label designs and Product User guides as required.

Qualifications / Experience
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position:
  • Minimum BSc, preferably Master’s Degree in a scientific or engineering discipline or equivalent with 8-10 years’ experience or more in the medical device or pharmaceutical industry, strong analytical skills, exceptional writing and interpersonal relationship skills.
  • Demonstrated knowledge of EU regulations, FDA regulations, ISO 9001, ISO 13485:2003, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards.
  • Demonstrate ability to increase value delivered by team through Performance management and successful challenging of underperformance.
  • Strong project Management skills with a proven track record of successful execution of major programs
  • Strong Leadership skills with a tested and proven desire to motivate individuals, and hold team members accountable for performance.
  • Experience in Process Excellence tools is highly desirable.
Personal Competencies
The competencies identified below are general descriptions of the behaviour and underlying characteristics needed to successfully perform this role at the required level:
  • Excellent communication skills (verbal and written) in particular clearly communicating any changes in corporate requirements and financial analysis and the ability to build and maintain relationships at all levels in the organization
  • Demonstrated planning excellence, developing action items that lead toward the accomplishment of long term goals by balancing short and long term objectives.
  • Problem Solving - takes an energetic and proactive approach to anticipating and preventing problems. Uses sound reasoning to arrive at conclusions and put permanent fixes in place.
  • Attention to detail to ensure accuracy and consistency of key plant data.
  • People Management – demonstrated ability to motivate team to achieve Plant goals and promote professional development.


For further information on this Quality Assurance Manager role in Galway please contact Bimi Felix on 086 8395533 / 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
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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Clients we are proud to work with

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