Quality and Validation Lead
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What you'll do
- Take ownership of and manage the Quality Management System (QMS).
- Ensure the business operates in line with SOPs and quality procedures.
- Maintain accurate quality documentation and records.
- Ensure documentation is appropriately reviewed, checked and approved.
- Support the business in maintaining compliance and audit readiness.
- Prepare for and support internal and external audits.
- Identify opportunities to improve quality systems and processes.
- Work closely with Technical, Manufacturing and Operations teams to embed quality standards across the business.
What they're looking for
- Experience working within a regulated quality environment ideally within a diagnostic, medical devices or scientific business.
- Knowledge of ISO 13485:2016; however, experience with ISO 9001 will also be considered.
- Experience working with and maintaining a QMS.
- Strong attention to detail and documentation skills.
- A proactive and hands-on approach to quality and compliance.
- The confidence to work independently in a standalone role.
- Strong communication skills and the ability to work well within a small team.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
About the opportunity:
We are looking for a proactive and detail-focused Quality Lead to join a growing manufacturing business specialising in lateral flow diagnostic products.
This is a standalone role where you will take ownership of the Quality Management System (QMS), ensuring the business operates in line with established procedures and remains compliant and audit ready.
Working closely with the wider team, you will oversee quality documentation, SOPs and processes, ensuring activities are correctly recorded, reviewed and approved. This is an excellent opportunity for someone looking to take the next step in their quality career and make a real impact within a small, growing business.
Key Responsibilities
- Take ownership of and manage the Quality Management System (QMS).
- Ensure the business operates in line with SOPs and quality procedures.
- Maintain accurate quality documentation and records.
- Ensure documentation is appropriately reviewed, checked and approved.
- Support the business in maintaining compliance and audit readiness.
- Prepare for and support internal and external audits.
- Identify opportunities to improve quality systems and processes.
- Work closely with Technical, Manufacturing and Operations teams to embed quality standards across the business.
Who we are looking for:
- Experience working within a regulated quality environment ideally within a diagnostic, medical devices or scientific business.
- Knowledge of ISO 13485:2016; however, experience with ISO 9001 will also be considered.
- Experience working with and maintaining a QMS.
- Strong attention to detail and documentation skills.
- A proactive and hands-on approach to quality and compliance.
- The confidence to work independently in a standalone role.
- Strong communication skills and the ability to work well within a small team.
Why you will love working here:
- Play a critical role in ensuring the safety, quality, and compliance of life-enhancing products.
- Gain exposure to a wide range of operations within a regulated and innovative business.
- Be part of a close-knit, friendly team where your contributions make a visible impact.
- Shape validation and quality practices that support growth, scalability, and operational excellence.
- Benefit from ongoing professional development.
- Company pension.
- Free on-site parking.
If you have the right attributes, skillset and feel you will be able to add value, then what are you waiting for…hit that apply button to find out more!
Company
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