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Quality Engineer

  • Job reference: 927599
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 11/09/2019

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


Job Purpose
Quality Engineer in the Cluster Material & Surface Technology Development group. The role involves utilizing Quality Engineering tools and practices for the effective and efficient development and/or transfer of products/processes into commercial operations. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve the capability of processes.

Main Responsibilities of the role

  • Team member representing the Quality function supporting projects in Materials Development with a focus on metals forming processes
  • Support Quality and Validation activities for product transfers and new product introductions
  • Responsible for ensuring conformance with current equipment, process, and systems validation regulations
  • Determine the implications of validations upon; Product Quality, Patient Safety, and Data Integrity
  • Assess effectiveness of measurement tools, destructive tests, non-destructive tests (measurement system analysis)
  • Determine process inputs and factors for variation where process capability is required
  • Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s
  • Develop pFMEA documentation to support processes as part of Validation process
  • Partner with R&D and other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges
  • Conduct investigation, bounding, documentation, review and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate
  • Support root cause analysis activities related to material processes
  • Communicate effectively with global functions and internal team on actions and deliverables
  • Provide timely and accurate reporting and management of escalations as appropriate on project activities
  • Ensure all activities comply with GMP, ISO and quality system requirements
  • Ensure that all health, safety and environmental requirements are fulfilled

Desired Experience and Background of the successful candidate

  • BSc in Engineering or Science with 2 years' experience in a medium to high volume manufacturing environment
  • 1 year in a similar capacity in a regulated industry (i.e. FDA/ISO)
  • Experience working in both an FDA and European regulatory environment is preferred with an in depth knowledge of 21 CFR 820, CFR 11 and European regulations associated with the medical device industry
  • A thorough understanding of GMP/ISO and validation regulations
  • Technical training (Six Sigma Black Belt / Statistical Engineering) and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
  • Problem solving engineering expertise (Six Sigma, SE or A3)
  • Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred
  • Strong verbal and written communication skills
  • 5 yrs experience in a regulated environment
  • 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 is desirable
  • Knowledge of lean manufacturing
  • Five years' experience as Quality Engineer working in a cGMP environment preferably in medical device
  • Flexible - Calmly reacts to the unexpected
  • Credible - Accountable for decisions
  • Innovation - thinks laterally but within a compliant framework
  • Structured problem solving and decision making skills working in a team environment
  • Must have good written and presentation skills and be able to communicate effectively throughout organization
  • Demonstrated Experience working with data base applications desired
  • Experience in performing Design of Experiments (DOE) and leading

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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