6 months ago
Job ID : 81107BR
Location : United Kingdom - Runcorn
The job: Quality Assurance Engineer (Band 6)
A full product lifecycle engineer opportunity, being responsible for monitoring the total Quality lifecycle for a specific portfolio of Anatomical Pathology products. If you have a passion for creating Benchmark Quality, Constructive Change and Continuous Improvement, it would be great to connect, collaborate and innovate. The successful candidate will have the ability to work autonomously and cross functionally, both nationally and internationally and will have the dynamic drive to take Good and make it Great.
Where will you work?
Reporting to the Quality Assurance Manager, you will be based at our Runcorn site – a global Centre of Excellence for the Anatomical Pathology Division.
What will you do?
* Directed by risk based and predictive statistical data analysis, drive product and process Quality improvements, (utilizing finite root cause analysis, preventative counter measures and sustainable corrective actions) throughout the assigned product portfolio’s full lifecycle.
* Assure Verification of Effectiveness (VOE) measures are implemented, monitored and aligned with all actions, on the assigned product portfolio.
* Assure that the assigned product portfolio and applicable processes and procedures remain in compliance with IVD regulatory and ISO13485 Quality requirements.
* Facilitate cross functional Quality improvement events to champion Lean Continuous Improvement process and product initiatives.
* Review all current inspection and testing protocols utilized within the assigned product portfolio and develop / implement Continuous Improvement initiatives to assure that all inspection and testing protocols are Efficient, Effective, Fit For Purpose and are Simple to Assure and Govern.
* Perform Supplier Quality Engineering Investigations, Supplier Development Improvement Events and Supplier Assessments. (Strategically and Tactically. +/- 25% Travel Projected).
* Collaborate cross functionally, performing Post Manufacturing / In Field Quality Engineering investigations to resolve applicable Lifecycle Quality issues.
* Investigate and assure all internal and external discrepancies (non-conformance) are adequately documented, registered and resolved in alignment with internal procedures for the assigned product portfolio.
* Collaborate cross functionally with Production Engineering, Engineering Technical Support (ETS) and R&D to resolve Product Lifecycle Quality issues.
* Ensure that all Quality KPI Visual Management media for the assigned product portfolio is kept current with 360° Product Quality feedback and define / facilitate Continuous Improvement efforts to provide evolving data sets and process / product feedback, in a simple, easy to use and standardized way.
* Lead / participate in Practical Process Improvement – Lean Enterprise (PPI-LE) activities to drive Continuous Product & Process Improvements.
* Manage and facilitate the calibration of inspection, measuring and test equipment utilized within the assigned product portfolio.
* Define the Quality requirements in the evaluation of new or alternatively sourced components and monitor / evaluate any manufacturing trial activity.
* Ensure that all applicable Quality requirements are clearly defined and implemented and support the effective design transfer of new / updated products from R&D / Production Engineering into Manufacturing.
* Support and Improve the Quality Management System and Quality Policy as directed by QA Management / QMS Specialists.
* Provide appropriate support as required for internal and external audits.
Who we are looking for:experience, skills & abilities
* Progressive and forward thinking Quality Engineering Professionals, with experience of working within a continuously evolving and improving market sector.
* Bachelor’s degree, (Preferred) or equivalent experience in an Engineering / Quality Assurance discipline.
* Comprehensive experience of working with Medical Device / IVD regulated products, with knowledge of ISO13485 / FDA QSR Part 820 requirements or within a heavily regulated, equivalent industry.
* Comprehensive knowledge and the demonstrated ability to facilitate and perform complex Root Cause, Preventative Counter Measure and Corrective Action implementation.
* Comprehensive knowledge and the demonstrated ability to perform predictive statistical data analysis.
* Thorough knowledge of Lean Continuous Improvement / PPI lean methods (5S, Kaizen, Poka Yoke, PDCA, Standardized Work, Cellular Manufacturing, Kanban etc.)
* Excellent interpersonal, communication and customer focus skills both written & oral
* Demonstrated project management experience.
* Demonstrated ability to work in a time sensitive environment and the ability to work both collaboratively and autonomously on your own initiative.
* Excellent IT skills
* Comfort with + / - 25% travel (UK, European & International)
What’s in it for you:
* New role within Thermo Fisher’s Anatomical Pathology Division – at the forefront of Cancer diagnosis
* Working within an innovative team of fellow Quality committed professionals
* Attractive base salary, bonus & benefits including:
* BUPA healthcare coverage, Life Assurance policy (4 x base salary), pension scheme, Employee Assistance Program, 25 days annual leave & more
As the world leader in serving science, our work is more than something that fills our days. When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Each one of our 70,000 extraordinary minds has a unique story to tell. It’s not just a career, it’s a chance to realise your best – professionally and personally.
Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer. !