Hannah Milward at CK Science is currently recruiting for a Quality Assurance Support Engineer to join a large multinational organisation involved in the treatment of musculoskeletal systems with products that include joint implants, trauma devices and biologic products. This will be on a contract basis for approximately 6 months at their site in West Yorkshire.
The purpose of this Quality Assurance Support Engineer job is to provide quality engineering, process excellence support in a defined business unit / value stream environment for in-process, finished product, first articles and new product introduction.
As a Quality Assurance Support Engineer you will:
- Actively support all Compliance Initiatives with the Value Stream and Plant
- Actively support all defined Value Stream and Plant goals and objectives.
- Identify projects to resolve scrap, reprocessing and special causes that have a negative impact on Value Stream and Plant Goals and Objectives.
- Compile Quality Process Specifications for new/transferred products/processes
- Be responsible for the introduction and correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
- Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new products. Quality process specifications to be compiled for on site production and purchased for resale goods (Goods In Check procedures)
- Reviews product designs, test protocols and co-develop critical characteristics/tolerances for initial testing and validations and subsequent routine manufacturing controls.
- Assist and where appropriate lead in the compilation and execution of validation protocols for new product/processes and software.
- Ensure correct implementation as per standard validation procedures.
- Re-validate as required due to engineering change, deviation analysis or upgrade in systems and materiel.
- Manage QA related change control for specific projects as directed
- Participates in process evaluations (e.g. FMEAs).
- Devises and implements methods and procedure for inspecting, testing and evaluating plans for subsequent routine production.
- Support Quality System activities within manufacturing cells such as Internal Audits, complaint investigations, close call and corrective action investigations.
- Perform/document dimensional/visual inspections and non conformance and deviations as required
- Manage a variable workload to meet operational requirements.
- Ensure that all Health, Safety and Environmental requirements are fulfilled.
Qualifications and experience required:
The successful candidate for this Quality Assurance Support Engineer job must have an engineering degree or equivalent in quality, manufacturing, engineering and/or experience in quality assurance/engineering. They must also have:
- Proven track record in Compliance & Continuous improvement projects
- Basic PC Skills.
- Ability to interpret engineering drawings/specifications.
- Familiarity in areas of various Inspection Techniques.
- Process Excellence Green Belt/Black Belt
- Working knowledge of Quality Systems (FDA/ISO) within a regulated environment
They will also have the following skills:
- High Attention to Detail
- Pro-active approach to Work
- High Standards
- Excellent Communication Skills
- Analytical Skills
- Team Player
- High level of Numeracy
- Highly Computer Literate
- Planner & Organiser
- Active Listener
- Technical Report Writing
How to apply:
For more information or to apply for this Quality Assurance Support Engineer role please contact Hannah Milward at CK Science on 0114 283 9956 or email email@example.com. Please quote reference SH23883 in all correspondence.