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Vacancy Details

Quality

Senior Engineer, Supplier Quality Compliance - Contract - Limerick

Contract Type: Contract
Sector:
Location: Limerick
Date: 13/12/2018
Job Reference: 96017
Contact Name: Bimi Felix
Contact Email: bimi@hero.ie

Job Description

Contact: Caroline Kingston
Email: caroline@hero.ie
Telephone: 0868395531

Senior Engineer, Supplier Quality Compliance - Contract
Our client, a medical device company in Limerick are currently looking to recruit a Senior Engineer, Supplier Quality Compliance for their site, on a contract basis.

You will collaborate with the strategic sourcing, auditing and development groups to understand the capabilities and competencies of suppliers to meet our requirements and continually meet and adapt to our product quality and regulatory requirements.

This role will provide coaching and guidance to the SQE team to ensure compliance to technical and regulatory requirements. This person will also act as the Single Point of contact for communication of issues for the suppliers within their commodity alignment.
  • Technical understanding of manufacturing prints and tolerencing
  • Knowledge in statistics
  • Strong communication skills
  • Strong problem solving skills
  • Strong team player
  • Good understanding and ability to work with Microsoft Office
  • Basic understanding of manufacturing processes
  • Fluent in written & oral English
  • Mobility to international assignments
  • Willing to travel in support of business needs to different geographical locations
  • Demonstrated interpersonal skills

Roles & Responsibilities
  • Ownership for supplier quality performance and measurement including KPI’s and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews
  • Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
  • Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers
  • Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
  • Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes
  • Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders
  • Participate in the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.
  • Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
  • Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned suppliers.
  • Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions
  • Deliver continuous improvement activities focusing on supplier quality
  • Participate as required in SCRB in conjunction with key stakeholders
  • Support assessment of supplier changes
  • Participate in supplier audit program – planning, execution and closure
  • Participate in supplier reviews for assigned suppliers as required
  • Participate in cross functional projects both locally & globally as required
  • Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.

Professional Requirements- Required:
  • Bachelor’s Degree in Engineering or Science fields
  • Minimum of 2 years’ experience in manufacturing environment or equivalent.
  • Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
  • Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
  • Demonstrated working knowledge to positively influence supplier quality performance
  • Analytical and problem solving capabilities with the ability to draw insights from data quickly and to define executable actions
  • Ability to plan, organize and implement multiple concurrent tasks
  • Strong communication/ influencing skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
  • Demonstrated ability to work in cross-functional team environments
  • Willing to travel in support of business needs to different geographical locations.
  • Good knowledge of continuous improvement methodologies

Professional Requirements- Desirable:
  • Preferred industries are medical device, aviation, aerospace, automotive and defense
  • Internal Quality Auditor Qualification either in AS 9100 or ISO13485,CFR820 or comparable industry standards and regulatory requirements

Personal Competencies
  • Must enjoy working in team environment
  • Must demonstrate strong collaboration and communication skills.
  • Highly motivated and able to build close relationships internally and externally.
  • Demonstrated ability to prioritize and deliver against timelines
  • Must demonstrate multitasking skills as this individual will be responsible for multiple tasks at the same time.
  • The individual should enjoy working in a dynamic and results oriented team environment focusing on quality, compliance and customer satisfaction


For further information on this Senior Engineer, Supplier Quality Compliance role in Limerick please contact Caroline Kingston on 0868395531 / caroline@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


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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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