Accessability Links
Cookies on our website
By continuing to use this website we will assume you are happy to receive cookies as outlined in our cookie policy
Accept Policy

Senior Quality Engineer



Location:
Cork
Salary:
Negotiable
Sector:
Engineering, Pharmaceuticals, Biopharmaceuticals / Biologics, Medical Device
    Apply via LinkedIn
This vacancy has now expired.

Senior Quality Engineer

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.

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

Our story in two minutes
A quick look at what we do...

At Berkley Group, we approach resourcing and recruitment in a way that’s distinctly insightful and personal. We have outstanding knowledge in our four specialist areas: IT, Pharmaceutical & Life Sciences, Engineering and Search & Selection. But as you’ll discover, it’s how we apply this knowledge that makes us different.

Our expertise spans the globe, so we can reach further for the right solutions. And we’re able to deal with a broad range of challenges because we're part of Rethink Group: one of the world's fastest growing providers of talent management, business solutions and recruitment.

Have more time? Learn more