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Quality Engineer

  • Job reference: 930051
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 17/02/2020

Orion Group Life Sciences have an exciting opportunity for a Quality Engineer for our Multinational Medical Devices client based in the Cork area on an initial 12-month contract.

Main Responsibilities of the role

  • Provide overall quality assurance leadership in the management of suppliers engaged in the
    production of company products
  • Provide complex product team support for quality system design and audit, compliance
    assessment, and for support of steady state manufacturing processes
  • Supplier Development including Robust process implementation and Inspection Readiness
  • Change control management and qualification of supplier process changes and supplier
    transfers programs
  • Supplier Process validation and approval in line with internal and Regulatory requirements
  • Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO)
  • Promote continuous improvement and Process Excellence activities within the Global Supply
  • Resolve problems & eliminate constraints to ensure project and supply targets are met
  • Work with the Sourcing teams to ensure the supply base is optimized to reflect the most
    efficient processes
  • Identify requirement to transfer identified products to alternate supplier or obsolete
  • Execute product equivalency assessments
  • Lead PVE with responsibility for associated documentation
  • Escalate timeline risk with mitigation recommendations
  • Collaboration with internal cross-functional team members and suppliers on timeline
    execution for SQE responsibilities
  • Liaise with internal stakeholders to ensure any supplier-based decisions are understood
    and accepted at site level
  • Interface with partners in Source, R&D Engineering, Manufacturing Engineering,
    Receiving Inspection, Manufacturing Quality Engineering, Quality Systems and suppliers serving multiple industries
  • Challenge critical thinking skills by solving supplier challenges, such as timely material
    qualification/maintaining production yield, while simultaneously navigating quality system
    requirements, engineering best practices, and supply chain demand
  • Take accountability for supplier qualification and performance by developing strong
    relationships with supplier executive leaders to drive improvements throughout the value chain
  • Manage deliverables in a fluid environment with varying levels of complexity while
    maintaining alignment with multiple stakeholders

Desired Experience and Background of the successful candidate

  • A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or
    related discipline
  • A minimum of 5 years of experience in a highly regulated industry is required/ Five years' experience as Quality Engineer working in a cGMP environment preferably in medical device
  • Experience in the Medical Device industry and/or Pharmaceutical industry is required
  • FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO
    13485 knowledge required
  • Six Sigma, Lean, or Lead Auditor Certification and trainings an asset
  • Experience in performing Design of Experiments (DOE) and leading Failure Mode Effects Analysis (FMEA)
  • Experience of the design and qualification documentation standards to current FDA expectations
  • Knowledge of statistical packages and Microsoft Office systems required
  • Proven ability to review and critique Quality Critical technical documents
  • A good understanding and working knowledge of FDA and ISO regulations
  • Structured problem solving and decision making skills working in a team environment
  • Ability to participate in or leading cross functional project teams
  • Must have good written and presentation skills and be able to communicate effectively throughout organization
  • Demonstrated Experience working with data base applications desired
  • Ability to set priorities while ensuring compliance is not compromised

#medicaldevices #medical #device #13485 #multinational #product #implant #engineering #FDA #quality #DOE #ISO #GMP

For more information on this role, call Daniel Ryan on +353868140295 or email for a completely confidential chat about this role and other opportunities using the reference number: 930051

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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