Quality Engineer
Would you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovation?
Do you want to make a difference?
If the answer is ‘yes’ then you’re just the kind of person we’re looking for!
We are looking for an organised individual to support all aspects of the Quality Assurance Function.
You will be ensuring that the quality management system meets all relevant requirements and building key stakeholder relationships.
THE ROLE
To support the business in ensuring that the quality management system meets all relevant requirements of the applicable regulations and standards.
(ISO 13485, FDA CFR 820 part 21, QSR’s)
To work alongside relevant teams to advise on quality related issues.
The Quality Engineer is responsible for assuring that processes and procedures are in compliance with the Quality Management System.
Reporting to the Quality Engineer Lead, The Quality Engineer is also responsible for identifying opportunities and supporting improvement and reduced variation in our manufacturing processes.
Problem Solving
- To be responsible for ensuring that all quality issues, and non-conformances are dealt with efficiently and promptly.
NCR/ CAPA
- Quality Engineers are responsible for ensuring that appropriate NCR/CAPA investigations are carried out in conjunction with the relevant departments using problem solving tools to identify root cause and implement effective corrections / corrective actions.
Data Analysis
- Responsible for quality monitoring.
- Review non-conformance and other manufacturing metrics to identify CAPA opportunities.
- Analyse and review process capability data and other quality metrics in order to identify specification or process changes to manufacturing processes.
Documentation
- Updating documentation where required using the standard format templates, ensuring documents are updated in a timely manner.
- To contribute to the development and management of policies and procedures within the quality engineering department.
Process validation / Equipment
- Work with Operations on validation protocol development, documentation, and approval (IQ, OQ, PQ) to ensure effectiveness in conjunction with the validation team.
- Support the documentation and process management in validation- IQ, OQ, PQ.
Quality representative on Process Changes / Projects
- Support the business in reviewing proposed changes to ensure changes are in line with internal and external Quality standard requirements and impact is evaluated.
- Ensure product verification and process validation requirements are reviewed and defined appropriately where applicable.
Audits
- To aid in periodic internal audits as directed by the QA Auditing team
- To represent the quality engineering department during external audits
Projects
- To actively drive forward improvement projects in order to meet timelines.
- Participate in Process Improvement projects to support achievement of business and quality metrics.
Training
- To be the lead in training on quality related processes.
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IDEAL CANDIDATE
- Proven Experience within a Quality Engineering role related to Pharma/Medical Device manufacturing
- A degree in Scientific / Manufacturing / Engineering related area.
- In depth knowledge of working with FDA part 820, ISO13485.
- Strong communications skills to influence Senior Managers.
Working for us:
Founded in 1986 by a group of former researchers based at the University of Birmingham, The Binding Site is today recognised as a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency.
The Company is built on the success of its people and provides the ideal environment to meet a wide range of career aspirations. It recognises the value of its employees and looks to provide development and support opportunities to maximise the potential of its 1,100 staff.
Working at Binding Site means being part of a global community that delivers innovative solutions with shared ideas and a collective dedication to improving patient lives, worldwide.
Location: Birmingham-Edgbaston
Hours: 40 hrs
Benefits:
- Contributory Pension
- 25 days paid holiday plus bank holidays
- Medicash-taxable health benefit.