Senior Quality Engineer

PE Global is currently recruiting for a Senior Quality Engineer on behalf of our client based in Cork.

This is initially a 12 month contract.

The Senior Quality Engineer plans, conducts and directs engineering projects or studies
including complete projects requiring advanced knowledge of a specialized field. They
apply comprehensive and diverse knowledge of engineering principles and practices within
broad assignment areas. They may coordinate and direct activities of technical support staff
and are responsible for technical development of assigned staff.

Responsibilities:

Business Improvements

• 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 and quality compliance with the
  right skill sets for new product introductions, and product life cycle management.
  Compliance/Regulatory
• Review/analyze whether current product and processes (including actions or
  decisions conducted) are in compliance to standards such as the QSRs, ISO 13485,
• 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
  Review results of area audits to ensure that corrective and preventive
  actions are adequate.

New Product/Process Introduction

• 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.
  Product Quality, Control & Disposition and Performance Standards
• Lead and maintain Material Review Board.
• Conduct investigation, bounding, documentation, review and approval of non�conformances, CAPAs and customer complaints. Escalation of quality issues as
• Accountability and ownership for material identification, material segregation,
  classification of defect types including the successful application of these techniques
  on a day-to-day basis in manufacturing.
• Analyze/review effectiveness of preventive and corrective actions. Review root
  cause investigation according to an established process.
• Accountability and ownership of Quality metrics including maintenance and reviewing
  of leading and lagging indicators of quality

Product/Process Qualification

• Approve IQ, OQ, PQ, TMV or Software Validation
  Production/Process Controls including Control Plans
• Partners with Global Supply chain, Finished Goods and material suppliers to
  ensure appropriate application of process validation, process control, and risk
  management; and the investigation/correction of process failures when needed.
• Conduct stakeholder analysis to ensure that customer CTQs are known and
  adequately addressed in control plan
• Develop measurement systems/capabilities, destructive tests, non-destructive tests
  for 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.
• Assess and interpret common versus special cause variation in manufacturing
  processing and determine adequacy of current process limits.
  Risk Mitigation
• Document, justify, review or analyze whether a proposed change to a process will not
  enhance the risk level in some way beyond capability of current controls or whether
  change will result in potential non-compliance to a required standard such as the
  QSRs
• Assess the need for risk mitigation techniques given product classification, potential
  defect types, defect frequency, severity, patient risk, process capability, process
  controls, etc. Determine effectiveness of these techniques on previously
  implemented improvements
  Strategic
• Ensures effective quality strategies are created for the validation of test methods,
  process and design.

Education and Experience Required for Role
 

• A minimum of a Bachelors Degree, preferably in Engineering or related technical
  Generally requires 4-6 years related experience.
• Experience working in both an FDA and European regulatory environment is
• 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
• 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
• 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.
• Continuous Improvement Focus

Interested candidates should submit an updated CV.

Please click the link below to apply, call Chloe on +353 21 4297900 or alternatively send an up to date CV to chloe.slingsby@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***