Senior Quality Assurance Engineer

at  Marshall Group

Cambridge, England, United Kingdom -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate25 Oct, 2024Not Specified25 Jul, 2024N/AChange Control,Suppliers,Six Sigma,Lean Processes,Membership,Engineers,GroupsNoNo
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Description:

Senior Quality Assurance Engineer

  • Competitive salary and remuneration package including, 27 days holiday, pension contributions matched up to 9%, private healthcare.
  • Cambridge based the role has the opportunity for hybrid working (minimum of 3 days a week in the office).
  • We are relocating Marshall at the end of 2025. The planned date has yet to be confirmed but the Cambridge site will be moving to Alconbury Weald (PE28).

Why join Marshall in this role?
Marshall have an exciting opportunity available for a Senior Quality Assurance Engineer - this role is essential to ensure contractual commitments are assured with respect to quality requirements, product traceability, and product release process (issuing of CofC).

Responsibilities include:

  • Understanding Quality and Project requirements.
  • Identifying quality risk and work to mitigate, manage and escalate.
  • Overseeing the process of product sign-off on completion of the delivery process to give the customer assurance their requirements have been met.
  • Providing quality input and advice through the product lifecycle (attend appropriate milestone/gate reviews).
  • Identifying root cause and instigate permanent corrective actions for product quality issues.
  • Working with internal and external stakeholders to resolve quality issues that arise as quickly and efficiently as possible to prevent compromising quality and safety standards.
  • Liaison with Quality representatives at suppliers and subcontractors to ensure that all deliverables meet the approved specification.
  • Reviewing and acceptance of Supplier Quality Plans ensuring they meet contractual conditions as applicable.
  • Supporting assessment of the capability and competence of potential suppliers for the customer needs

Tasks:

  • Compiling and maintaining the Product Quality Assurance Plan.
  • Reviewing any contract amendments for the impact on the Quality Assurance Plan.
  • Support to Customer audits and product acceptance activities (FAT).
  • Conducting independent audits as required by the audit schedule to ensure that the Company remains in compliance with the requirements of relevant regulations and standards and to ensure the quality management system has been implemented and is being maintained.
  • Evaluation of product specific issues and product realisation processes investigation (8D process), ensuring prevention of recurrence.
  • Providing feedback on quality performance and Quality KPIs at the appropriate forums.
  • Participating in the development and refinement of Design and Process FMEA’s (Failure Mode and Effects Analysis).
  • Training both Quality team and broader organisation members on quality matters.

Please apply if you have most of the following:

  • Strong knowledge of Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP), Failure Mode and Effect Analysis (FMEA).
  • Excellent problem-solving skills with extensive experience in investigating QA issues and non-conformances.
  • Lean Manufacturing knowledge.
  • Understanding of ISO9001, ISO14001 and Health and Safety practices.
  • Experience in management and facilitation of Lessons Learned.
  • Fully IT literate: Microsoft Outlook, Word, Excel

Education:

  • BS in Management or Engineering or relevant qualification in Quality Management and/or Six Sigma.
  • Membership of an industry related Professional Body would be advantageous.
  • Experience of dealing with customers and suppliers.
  • Lead auditor qualification.

Experience:

  • Previous experience working in a similar position.
  • The ability to lead and/or support groups of technicians and engineers.
  • Extensive demonstrated quality experience, including audit, traceability management, change control, complaint handling and investigations experience.
  • Experience promoting LEAN processes and tools, best practice and sharing Lessons Learned.

Additional local needs

  • Hold a full UK driving license. Willing to visit Customer/Supplier, ad hoc meetings.

LI-Hybrid

LI-ER1

Marshall Group is an Equal Opportunity Employer
Marshall Group is an Equal Opportunity Employer
Marshall Group is an equal opportunity employer and values a diverse and inclusive workplace. All qualified candidates will receive consideration for employment without regard to age, race, colour, religion, genetic information, sex, sexual orientation, gender identity, national origin, disability status, or any other characteristic protected by law. For more information about Equal Opportunity in the Workplace please click
here

Responsibilities:

Responsibilities include:

  • Understanding Quality and Project requirements.
  • Identifying quality risk and work to mitigate, manage and escalate.
  • Overseeing the process of product sign-off on completion of the delivery process to give the customer assurance their requirements have been met.
  • Providing quality input and advice through the product lifecycle (attend appropriate milestone/gate reviews).
  • Identifying root cause and instigate permanent corrective actions for product quality issues.
  • Working with internal and external stakeholders to resolve quality issues that arise as quickly and efficiently as possible to prevent compromising quality and safety standards.
  • Liaison with Quality representatives at suppliers and subcontractors to ensure that all deliverables meet the approved specification.
  • Reviewing and acceptance of Supplier Quality Plans ensuring they meet contractual conditions as applicable.
  • Supporting assessment of the capability and competence of potential suppliers for the customer need

Tasks:

  • Compiling and maintaining the Product Quality Assurance Plan.
  • Reviewing any contract amendments for the impact on the Quality Assurance Plan.
  • Support to Customer audits and product acceptance activities (FAT).
  • Conducting independent audits as required by the audit schedule to ensure that the Company remains in compliance with the requirements of relevant regulations and standards and to ensure the quality management system has been implemented and is being maintained.
  • Evaluation of product specific issues and product realisation processes investigation (8D process), ensuring prevention of recurrence.
  • Providing feedback on quality performance and Quality KPIs at the appropriate forums.
  • Participating in the development and refinement of Design and Process FMEA’s (Failure Mode and Effects Analysis).
  • Training both Quality team and broader organisation members on quality matters


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Production / Maintenance / Quality

Software Testing, Clinical Pharmacy

BSc

Bs in management or engineering or relevant qualification in quality management and/or six sigma.

Proficient

1

Cambridge, United Kingdom