Job Description
Quality Manager
* Sovrin Medical Plastics Ltd
* Location: UK (on-site)
* Contract: Full-time, Permanent
About Sovrin Medical Plastics
Sovrin Medical Plastics Ltd is a well-established UK manufacturer specialising in medical device moulding and cleanroom manufacturing. With a long-standing reputation for quality, compliance, and technical excellence, we support leading medical and healthcare customers with precision injection-moulded components and validated manufacturing processes.
Operating within a regulated ISO 13485 environment, quality is central to everything we do.
The Role
We are seeking an experienced Quality Manager to lead and continuously improve our Quality Management System and ensure full compliance with ISO 13485 and applicable regulatory requirements.
This is a hands-on leadership role, working closely with Operations, Engineering, and Customers to ensure robust processes, effective risk management, and audit readiness at all times.
Key Responsibilities
* Own, maintain, and develop the ISO 13485 Quality Management System
* Act as site lead for external audits (customers, notified bodies, regulators) and internal audits
* Manage CAPA, deviations, non-conformances, and complaints through to effective closure
* Ensure compliance with regulatory and customer requirements for medical device manufacture
* Oversee document control, change control, and validation documentation
* Lead quality input into new product introduction (NPI) and process changes
* Manage supplier quality, including supplier approval and performance monitoring
* Drive continuous improvement and quality culture across the business
* Provide leadership and mentoring to quality team members as their line manager
Skills & Experience Required
* Proven experience as a Quality Manager (or Senior Quality Engineer) in a manufacturing environment
* Strong working knowledge of ISO 13485 (medical devices essential)
* Experience within plastic injection moulding, cleanroom, or medical manufacturing highly desirable
* Confident leading audits and interfacing with customers and external bodies
* Practical experience of CAPA, risk management, and validation activities
* Strong attention to detail with a pragmatic, solutions-focused mindset
* Excellent communication skills at all levels
* Strong IT skills for working in a data-driven environment (ERP experience desirable)
What We Offer
* Key leadership role within a respected medical manufacturing business
* Opportunity to shape and strengthen quality systems and culture
* Stable, long-term position in a growing and technically capable organisation
* Competitive salary, commensurate with experience