Connecting to LinkedIn...

Vacancy Details

Quality

Quality Engineer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 14/06/2018
Job Reference: 96261

Job Description

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

Quality Engineer

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

  • This position requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual, Design Control, Supplier Management, Corporate and other appropriate procedures for a variety of medical devices from concept through market introduction.
  • Maintain company compliance with Quality System Regulations and ISO 13485 standards. Experience with FDA and ISO inspections and registration is a plus.
  • Actively participates in Internal audits, CAPA System, Document/Change Control, and other activities covered under the Quality Manual, Policies and Procedures.
  • Provide customer-related quality and regulatory inquiries’ support.
  • Compiles and writes training material and conducts training sessions on QMS & Quality assurance activities.
  • Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner. Directs development and maintenance of internal/external standards relative to Design and Development,
  • Lead implementation of continuous improvement projects or act as subject matter expert for SPC, FMEA, Capability Assessments, MSAs, CI and Process Validation.
  • Lead and provide Project Management support as needed.
  • Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.
  • Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data.
  • Leads disposition of discrepant material and devises process to assess product quality and reliability.
  • Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration.
  • Manage and drive continuous improvement activities focusing on supplier quality.
  • Support supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier’s methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA.
  • Supports or may perform measuring, testing, and tabulating data concerning quality and reliability.
  • Acts as management representative in the absence of the lead quality engineer/manager.
  • All other duties as assigned.
  • Minimal travel may be required.

Minimum Education And Experience Requirements:
  • Bachelor degree in an Engineering/Science discipline.
  • 3-7 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485, with increasing responsibility.
  • Experience with FDA and ISO 13485 Certification inspections is a plus.
  • Must be adept in use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred).
  • Quality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include but are not limited to Statistics, SPC, Geometric Dimensioning & Tolerancing; Sampling, Design of Experiments, etc. Ability to analyze, understand and effectively communicate this technical material. Experience with Lean Manufacturing and Six Sigma is a plus.
  • Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision.
  • Knowledge and experience of process validations would be advantageous
  • Proven to be self-directed, self-motivated and able to prioritize and resolve competing priorities.
  • Strong team member with the ability to identify and drive quality improvements.
  • Must possess excellent verbal & written communication skills, which include but are not limited to presentation, organizational and management skills.

For further information on this Quality Engineer role in Galway please contact Bimi Felix 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.

Share this Job

Our Clients

With a reputation across three decades in the making, HERO Recruitment continues to impress our clients and candidates with our passion and dedication to our craft.

See More

What people say

Our strong reputation for quality placements in key roles has earned us the status of agency of choice. HERO Recruitment’s commitment to superior service is what sets us apart from our competitors and has rewarded us with many exclusive and semi-exclusive client and candidate relationships.  Here is what our clients and candidates say about us…

See More

“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

“Merit Medical have partnered with Hero for the past 10 years. During this time we have grown our employee numbers to 630 employees. Our experience of working with HERO is that they have a personal client focused approach, they know the market and they can deliver on the candidates.  The medical device market is competitive and our company success is dependent on the quality of our people, we want the best there is in the market so we can grow and in turn offer development opportunities to our people. 

Mary Collins,
Senior Director, Human Resources Europe
Merit Medical

“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