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Quality Engineer

  • Job reference: 933655
  • Location: Leeds, West Yorkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Engineering, Manufacturing & Facilities, Life Sciences
  • Date posted: 22/01/2021

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

Job Purpose

  • The Quality Engineer conducts assignments encompassing complete projects or portions of major projects.
  • They determine methods and techniques to be used or adapt standard methods to meet variations.
  • They coordinate phases of work internally and externally.
  • The Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle

Main Responsibilities of the role

  • Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
  • Review/analyse the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
  • Conduct benchmarking to develop more effective methods for improving quality
  • Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
  • Review/analyse whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
  • Champion's compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements).
  • Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
  • Supports new product introduction as part of design transfer
  • Support investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
  • Analyse/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process
  • Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
  • Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
  • Develop, interpret and implement standard and non-standard sampling plans
  • Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
  • Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits

Desired Experience and Background of the successful candidate

  • A minimum of a Degree, preferably in Engineering or related technical field. Generally, requires 2-4 years related experience.
  • Experience working in both an FDA and European regulatory environment is preferred.
  • This position will require relevant experience working in manufacturing/operations.
  • Knowledge of product/process Risk Management (FDA and ISO standards) is required.
  • Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
  • Good knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
  • The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to think on the feet and providing sound judgment is highly desired.
  • Good technical understanding of manufacturing equipment and processes is required.
  • Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
  • A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
  • Demonstrated project management and project leadership abilities are preferred


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For more information on this role, call George on +44 (0) 203994470 or email George.mcglone@orioneng.com for a completely confidential chat about this role and other opportunities.


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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