Quality Engineer
2 weeks ago
Job Description
We are seeking a highly skilled and detail-oriented Quality Engineer to join our team. As a Quality Engineer, you will play a crucial role in ensuring that our products meet the highest standards of quality and safety.
Job Purpose
To work on projects to improve process capability and to reduce non-conformances by utilising Statistical Process Control (SPC) principles.
To support investigations into issues that arise at sub-contractors using Six Sigma (D. M. A. I. C) principles to understand and contain issue at source.
Provide assistance to QC and conduct release activities across existing and new product lines, processes, or equipment at suppliers with the Technical and R&D teams.
Following the identification of a potential or recorded non-conformance relating to product, liaise and work with suppliers to understand the root cause and establish a containment plan. If required, hold a Material Review Board meeting, and raise a Vendor Corrective Action report accordingly and ensure effective Corrective and Preventative Action verification and effectiveness.
To perform process audit system based upon identified risks.
Identify potential risks to Medtrade through a predict and prevent approach, working with internal teams to consider known and potential issues that might occur with materials or products. To then propose preventative actions to and avoid mitigate risks.
To work away from home, both domestically and internationally as and when the business requires.
The role is split primarily between the office and sub- contractors/customers.
Education/Qualifications/Experience
Required
Degree of equivalent in a quality of engineering discipline
Current clean UK Driving license or equivalent
Knowledge/trained in Six sigma and / or other quality tools e.g. DMAIC, 8D, PPAP, APQP
Knowledge/training in Lean manufacturing
Knowledge/training of ISO:13485
Computer skills including competence in:
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Desirable
Raw Material, Component, Product and Process knowledge for Medical Device applications.
Mixing, Coating, Converting,
Packing process/equipment knowledge/exposure.
Equipment/Process Validation knowledge/exposure.
Cleanroom production and Health & Safety awareness.
Project planning/management
QC release activities, documents, inspection, function testing
Non-Conformance controls and experience of equivalent MRB, VCA, CAPA processes and procedures.
Monitoring and trending of Data.
Supplier Process Audits.
Experience of using Minitab or similar program.
Competencies/Personal Skills/Behaviours
Ability to work alone or as part of a team.
Developed inter-personal and communication skills.
Flexible and self-motivated.
Strong verbal and written communication
Problem Solving
Systematic and logical
Ability to lead meetings and presenting to a varied audience.
Keen attention to detail.
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