Senior Quality Engineer

Posted 29 July 2022
Salary Negotiable
LocationEngland
DisciplineLife Science
ReferenceCR/056236_1659099117
Contact NameVictoria Armitstead

Job description

We at Orion Group are currently recruiting a Senior Quality Engineer on behalf of one of our Multinational Medical Device Clients in Cork to work on a 12-month contract

Major Responsibilities & Duties:

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.

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.

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

Qualifications

  • 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

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.