Quality Assistant - Audits
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!
You will be responsible for ensuring the Quality Management System (QMS) meets all current Regulatory requirements relevant to our business by carrying out internal audits, acting on any NCRs found and reporting the findings.
The successful candidate will be responsible for ensuring that our supplier management system meets all regulatory and business requirements and that supplier qualification, audits and monitoring are appropriate for the products that they supply.
Principal Duties and Responsibilities:
- Management of specific internal audits within the overall program. Ensuring that audits are carried out as planned and that any NCRs are documented and followed up appropriately.
- Advising on appropriate corrective action to take when NCRs are documented and ensuring that any action required is taken within a timely manner. Ensuring that all work undertaken is clearly documented and can be followed by external auditors and regulatory bodies.
- Assisting with external audits of The Binding Site – escorting auditors and customers and providing information requested during said audits and inspection. Assisting in the resolution of any NCRs documented during external audits.
- Undertaking audits (both desktop and physical) of key suppliers and reviewing data to contribute to the supplier management program.
Essential:
- A’ levels or equivalent in Science.
- Working knowledge of ISO13485, MDSAP and regulations e.g. IVDR, FDA Part 820, 806 and 803.
- Experience of working within QA or RA environment within an IVD or medical device company.
- Excellent communication skills – both verbal and written
- Excellent attention to detail.
- Good working knowledge of Microsoft Office and database experience.
- Audit planning, execution and follow-up.
- The ability to follow processes
- To have an inquisitive mind
- The ability to work as part of a team
- To be Friendly and approachable
- To be flexible to the needs of the business
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: Birmingam
Hours: 40 hrs
Benefits:
Competitive Salary
25 days paid holiday plus bank holidays
Pension
Medicash Healthcare Plan