Role details

Quality Process Engineer

West Yorkshire   •  Temporary

Bullet points

  • Reports to Quality Engineering Manager
  • 12 month contract

About Our Client

Global FMCG Manufacturer

Job Description

  • Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
  • Review/analyze 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, quality compliance, quality leadership talents with the right skill sets for new product introductions, and product life cycle management.
  • Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO,
  • EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
  • Conduct periodic line audits to assess for production controls such as lot segregation.
  • Review results of area audits to ensure that corrective and preventive actions are adequate.
  • Provides supervision, mentoring, coaching, performance review, developmental plans, and succession planning for others
  • Develop measurement systems/capabilities, destructive tests, non‐destructive tests for additive manufacturing processes
  • Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
  • 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.
  • Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.
  • Partnership with other functions to establish business priorities and resource allocation
  • Ensures effective quality strategies are created for the validation of test methods,
  • Supports execution of strategic vision or plan by collaborating with other quality leaders
  • to identify required Quality Engineering skills and competencies.

The Successful Applicant

  •  A minimum of a Bachelors Degree, preferably in Engineering or related technical field.
  • Generally requires 5‐8 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.
  •  In‐depth knowledge of product/process Risk Management (FDA and ISO standards) is
  • required.
  •  Experience with a proven track record of implementing appropriate risk mitigation.
  •  Technical training and experience using Statistics, Lean and Six Sigma Methodologies is
  • required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
  •  Strong 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 required. 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.
  •  Strong mentoring, coaching and leadership skills are required.
  •  Advanced knowledge and proven leadership in the areas listed in the Duties and
  • Responsibilities associated with the position.
  •  Demonstrated project management and project leadership abilities are required.

What's on Offer

The client is paying between £28-38 p/h

Apply for this job

Click the Apply or LinkedIn button below or contact Lauren Allanson on +44 113 388 9047 quoting job reference 13725339
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