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Quality Engineer

  • Job reference: 928642
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 27/11/2019

Orion Group Sciences are looking for a Quality Engineer for our multinational medical devices client based in the Dublin area on an initial 12-month contract with the potential to extend.

Job Purpose

The role is a project assignment to ensure that the client meets the new requirements of Economic Operators under EU MDR 2017/745. The scope of the Medical Device Regulation has changed and now extends to all economic operators in the supply chain. The new Regulation specifies obligations and responsibilities for all economic operators including manufacturers, importers, distributors and authorized representatives. This project will focus on ensuring that the appropriate processes and systems are in place to fulfil the obligations under the new regulation.
The role will include working on multiple QMS (Quality Management Systems) and require candidates to demonstrate leadership skills.

Main Responsibilities of the role

  • Understand the obligations of Economic Operators under the EU MDR 2017/745
  • Prepare Gap assessment for the client
  • Work with franchise and local teams to execute gap assessments to EU MDR 2017/745
  • Manage project timelines and deliverables
  • Work on updating procedures and Quality Agreements as needed
  • Ensure readiness for EU MDR audits specifically under the remit of Economic Operators

Desired Experience and Background of the successful candidate

  • University / Bachelor's Degree or Equivalent
  • Five years' experience as Quality Engineer working in a cGMP environment preferably in medical device
  • SIX SIGMA - Certification
  • 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
  • Knowledge of lean manufacturing
  • Ability to set priorities while ensuring compliance is not compromised
  • Experience in performing Design of Experiments (DOE) and leading
  • Knowledge of EU MDR 2017/745
  • Proven experience of implementing / compliance to Standards
  • Technical writing skills
  • Strong influencing, negotiation skills
  • Project Management experience
  • Credible - Accountable for decisions
  • Self-Motivated - requires minimal direct supervision
  • Results focused - maximizes business benefit from all activities
  • Innovation - thinks laterally but within a compliant framework
  • Organized - Able to cope with extensive documentation and planning requirements
  • 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

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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