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The role of the Quality Engineer ensures the company’s products, services, and quality system processes are of the highest quality, effectiveness, and reliability across the EMEA and APAC regions.
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Our Role
- Designs, implements, and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.
- Contributes to the setting of strategy, objectives, and plans for the quality system through quality engineering expertise.
- Designs methods, metrics, and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products in line with company quality standards and Key Performance Indicators (KPIs).
- Support new product development by representing the quality area during new product or process development during the planning, design, implementation, risk analysis and management, execution and review, and product release.
- Identify quality deployment requirements during the development and implementation process.
- Executes internal audits within established manufacturing and production controls to ensure compliance with in-house and external specifications and standards. Support external audits including customer and certification audits, guiding/driving corrective action analysis, implementation, and validation of findings.
- Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. Monitor process deviations and customer complaints for trends and root causes.
- Resolve supplier failures and issues requiring corrective action and preventive action promptly
- Participate in supplier evaluations and/or audits. Ensure suppliers adhere to performance criteria and drive improvements, if necessary.
- Support Service Centers as the quality representative throughout the development and onboarding of Services Centers. Conduct internal surveillance auditing of Service Centers.
- Performs additional duties as assigned.
This is a site-based role, located in Leighton Buzzard. Commutable from Bedfordshire, Milton Keynes, Buckinghamshire, Luton, Northamptonshire and surrounding areas
What you will need to be successful..
- Bachelor’s degree in Engineering
- Two (2) years of experience in Quality Engineering
- Excellent analytical, organizational, negotiation and oral/written communication skills
- Ability to operate in a fast-paced environment and handle multiple projects simultaneously within set timeframes
- Proficient with Microsoft Office, Excel, Visio, and other similar business applications
- Proficient with Quality and Statistical analysis software
Preferred Qualifications
- Bachelor’s Degree in Materials, or Packaging Engineering
- Experience in an ISO 9001 certified and/or life science regulated environment (pharmaceutical, biologics, or medical device)
- Experience working with Quality Management, Electronic Document Management, Product Data Management (PDM), Product Lifecycle Management (PLM), or Enterprise Resource Planning (ERP) systems
- Certification in Quality Engineering, Quality Management, 6-sigma, lean
- Project Management skills
In return we can offer you…
- A competitive salary
- Company bonus scheme
- Life assurance 4x salary
- Salary sacrifice pension
- Group income protection
- Development programmes
- Quarterly company events
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About us…Peli BioThermal is a global leader in the design and manufacture of single use and reusable temperature-controlled packaging solutions for the highly regulated pharmaceutical, biotech, and clinical trials industries. Peli BioThermal is a great place to work and offers employees the opportunity to flourish and excel in a high-growth, fast-paced, creative, and exciting environment!
What happens next?If your application is successful, you’ll be invited to a first stage screening interview with one of our local HR Partners. At Peli BioThermal it’s important to ensure our talent promotes and embraces the Pelican Universal Behaviours, in order to unite and work together as one global team.
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