Medical Device Quality Assurance Specialist
6 days ago
Job Summary
Redshore is seeking a highly skilled Quality Systems Engineer to join its team in Slough. As a Quality Systems Engineer, you will be responsible for the management, development, implementation, and continual improvement of an efficient and effective Quality Management System (QMS).
Key Responsibilities
- Plan and conduct internal quality audits (EN ISO 13485:2016) in accordance with the audit schedule and company procedures and work instructions, ensuring all applicable regulatory requirements are met.
- Ensure follow-up activities are conducted, including verification of actions taken and reporting of verification results.
- Identify, record, and investigate nonconformities/potential nonconformities in accordance with company procedures and work instructions.
- Identify and implement process improvements in conjunction with Line Managers/Process Owners to ensure processes required for the QMS meet the requirements of relevant ISO standards and applicable regulatory requirements.
Requirements
- Experience of working within a Medical environment with exposure to ISO 13485.
- Degree-qualified in an engineering or medical subject.
- Good systems experience with strong regulations knowledge.
Benefits
- GBP 45,000 - GBP 52,000 - Basic Salary
- Pension
- Life Assurance
- Medical Cover
- Excellent Holidays
- Training and Development
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