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Quality Engineer

  • Job reference: 934206
  • Location: Limerick
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 23/02/2021

Orion Group Life Sciences have an exciting new opportunity for a Senior Quality Engineer with one of Multinational Medical Device Clients based in Limerick on an initial 12-month contract with the view to extension thereafter.

  • Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes
  • Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).
  • Addresses and corrects product and process complaints.
  • Reports on contract manufacturer performance metrics and ensures management reviews.
  • Oversees audits of all quality system categories to assess compliance to process excellence standards.
  • Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management
  • Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
  • Responsible for supporting the activities of Operations/Engineering/information management in building quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness
  • Leads and executes upgrades to Quality System
  • Support QA programs in assuring compliance to the pertinent regulation
  • Identify and lead cost and technical improvements under the departments continuous improvement program.
  • Provide key inputs and leadership into transformational process developments.
  • Project Management - provide timely and accurate reporting on project activities.
  • New Product Introductions & Product Transfers
  • Lead or actively participate in cross-functional teams to ensure New Product Introduction/Research and Development projects are completed in a timely and efficient manner.
  • Actively interfacing with cross-functional team members, always practicing good team work in support of day to day operating requirements.
  • Demonstrate strong leadership and a clear identifiable work ethos within the team.
  • Develop and maintain a Credo & Behavioural Standards based culture within the group.
  • Ensure all process developments, NPI etc. are managed in accordance with the Quality management system.
  • Implementation of safety/environmental requirements on purchase of all new equipment.
  • Work with team leader to develop and implement strategic engineering Goals & Objectives.
  • Support the implementation of all engineering and plant strategic initiatives.
  • Ensuring continuous improvement and understanding of measurement systems used on-site, driving down variance in test methodology.
  • Develops site knowledge on manufacturing process knowledge, and monitors inputs and outputs to the processes, and implements and drives corrective actions.

Education and Experience Required for Role

Essential:

  • Degree Qualified with 3-5 years' relevant experience in Medical Devices/Pharmaceutical Industry
  • Ability to work on own initiative
  • Flexible work ethic
  • Attention to detail
  • Excellent working knowledge of process excellence / QE tools such as pFMEA, SE, statistical analysis, SPC
  • Excellent IT skill e.g., experience in Minitab, excel reports

Desirable:

  • CAPA and RCI experience
  • Risk management experience
  • Automated process controls experience
  • Good presentation skills

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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