Collins McNicholas

Role Purpose:

  • Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.

Role Responsibilities:

  • Will work within the quality operations team, under minimal supervision, with responsibility for quality related activities, including, but not limited to the following:
  • Work closely with operations and the business functions to ensure quality performance of product and processes.
  • Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
  • Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
  • Analysis and review of concession requests.
  • Review and approval of change management activities.
  • Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
  • Support execution and analysis of QATs.
  • Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
  • Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
  • Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
  • Proficiency in statistical methods and application.
  • Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
  • Assist in the development, responsible for review & approval of process and equipment validation/qualification.
  • Support manufacturing transfers to other plants/facilities, leading quality activities.
  • Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
  • Coach and mentor others in quality topics and activities.

 

Role Requirements:

  • Bachelor degree in Science, Engineering or equivalent/ related subject and 2 or more years of work experience in a quality discipline, or
  • Masters of Science, Engineering or related subject with 0 years of experience
  • Previous experience in a regulated environment desirable.
  • CQE or equivalent course work / experience desirable
  • Proficient in understanding of Medical Device manufacturing processes desirable.
  • Familiarity with ISO 13485, GDP, GMP desirable.
  • Lean Six Sigma training a distinct advantage.
  • Excellent communication skills and attention to detail.
  • Have a good understanding of engineering and quality practices & methods.
  • High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
  • Self-starter with demonstrated efficient work methods, analytical & problem-solving skills and ability to handle multiple tasks in a fast-paced environment.
  • Must be willing to work as part of a multi-site team, with some travel required.
  • Working knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
  • Highly developed problem solving and strong analytical skills.
  • Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach
  • Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
  • Manages change well and adopts a continuous improvement orientation to the role
  • Excellent English (both oral and written)
  • Ability to be the voice of Quality when dealing cross functionally

 

For a confidential discussion and more information on the role, please contact Emer O’ Callaghan on 021 4911061 or email emer.ocallaghan@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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