At a Glance
- Tasks: Ensure ISO 13485 quality management system is established and continuously improved.
- Company: Fast-growing medical device company with a focus on quality and compliance.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Other info: Opportunity to work on exciting projects and support continuous improvement.
- Why this job: Join a dynamic team and enhance your skills in quality assurance.
- Qualifications: 3+ years in quality assurance within FDA and EU regulated environments.
The predicted salary is between 40000 - 44567 £ per year.
Lenn Tech Search are working with a fast growing medical device client who have an urgent need for a Quality Systems Specialist to join the QA & compliance team.
You will play a key role in ensuring our ISO 13485 quality management system is established, implemented, maintained, monitored, and continuously improved.
This role will have responsibilities including creation and quality review of QMS documentation, ownership of projects driving continuous improvement, management and participation in audits and investigations, monitoring of key QMS performance indicators.
You will also develop subject matter expertise in management of the company’s electronic QMS.
Main Duties
- Manage and coordinate document control and training activities via the electronic QMS (e QMS).
- Contribute to the creation and preparation of documentation; manage the review and approval of documents, including SOPs, WIs and ensure compliance to Good Documentation Practices, regulatory standards, and company operating requirements.
- Provide support to users of the e QMS, assisting with initiating change requests and uploading associated documentation.
- Support the delivery of the Internal Audits, Non-conformance and CAPA management system in the business.
- Identify and own opportunities for continuous improvement across the Quality Management System.
- Perform QMS Gap Analysis to ensure appropriate reviews and approvals have taken place.
- Supporting extension to ISO Scope to include manufacturing of medical devices.
- Supporting notified body and external audits.
Education and Experience
- Experience of working in a quality assurance role within FDA and EU regulated QMS frameworks for medical device design, development, and manufacture, specifically for SO 13485.
- 3+ years experience in a similar role.
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QMS Specialist in Oxford employer: LennTech Search
Join a dynamic and rapidly expanding medical device company that prioritises quality and compliance, offering a collaborative work culture where your contributions directly impact patient safety and product excellence. With a strong focus on employee development, you will have access to continuous training opportunities and the chance to grow your expertise in ISO 13485 quality management systems. Located in a vibrant area, this role not only provides meaningful work but also a supportive environment that values innovation and improvement.
