Senior Quality Engineer

  • Reference: CJ45987
  • Job Type: Permanent
  • Location: Cork, Cork City, Munster
  • Category: Engineering, Technical & Manufacturing

Role Responsibilities:

  • Will work within the quality operations team, with moderate supervision and mentoring, 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.
  • Approval of NC, builds proficient in problem solving and root causing activities.
  • Participate in the development and improvement of the manufacturing processes for existing and new products.
  • Review of change management activities.
  • Maintain KPIs 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, familiarity in the science of Human Factor identification, reduction and mitigation.
  • Develop understanding of risk management practices and concepts, ability to become proficiency in process risk.
  • Develop understanding of optimization of inspection methods and sampling. Support First Article Inspections.
  • Developing proficiency in statistical methods and application.
  • Participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audits preparation building confidence and proficiency in interactions with same.
  • Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
  • Support manufacturing transfers to other plants/facilities, execution quality activities.
  • Responsible for initiation, internal containment and support of ship and product holds for potential product escapes.

Minimum Qualifications:

  • 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 Med 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 Eloísa Ruiz on 021 4911066 or email eloisa.ruiz@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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Eloísa Ruiz

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  • Eloísa Ruiz
  • Recruitment Consultant
  • 021 4809 118
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