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Vacancy Details

Quality

107043 - Senior Compliance & Audit Specialist - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 14/02/2020
Job Reference: 107043
Contact Name: Clara Burke
Contact Email: science@hero.ie

Job Description

Senior Compliance & Audit Specialist - Galway - 107043
Senior Compliance & Audit Specialist
My client a leading medical device company is looking to hire a Senior Compliance & Audit Specialist for their Galway site.

Purpose
My client provides a centralized internal audit services as a core quality service for the CVG network. In this exciting role as a Senior Compliance & Audit Specialist you will have direct responsibility for conducting internal quality system audits and implementing the global Cardiac and Vascular Group (CVG) compliance strategy.

Key Duties
  • Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities.
  • Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents.
  • Interprets and implements applicable regulations as they apply to products, processes, practices and procedures.
  • May counsel stakeholders about these requirements as necessary.
  • Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
  • Analyses audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.
  • Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.

Key Skills & Experience
  • Bachelor’s degree with 4+ years of Quality Management Systems, Regulatory, Compliance and/or Audit experience or Advanced degree with 2 +years of Quality Management Systems, Regulatory, Compliance and/or Audit experience.
  • Degree in Science or Engineering
  • Quality System Lead Auditor certified
  • Experience with FDA, MDSAP, EUMDR or similar regulated bodies medical device requirements.
  • Experience auditing Quality Systems to global requirements
  • Experience within healthcare industry (e.g. medical device, biotech, pharma)
  • Experience in any of the following key areas: IT (cybersecurity), Manufacturing Operations/ Process Controls, Design and Development and/or Post-Market Surveillance Medical Device Requirements, Pharma/ Combination Device/ Complaints Management.
For further information on this Senior Compliance & Audit Specialist role in Galway please contact Clara Burke on 086-8168273 or email science@hero.ie

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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”.

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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,
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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,
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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,
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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”.

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Orla Keady-Giblin,
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Ingersoll Rand – Thermo King

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

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Valeo Vision Systems
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