Quality Assurance Consultant
3 weeks ago
10-03-2023
- JOB TYPE
- Contract
- EMP TYPE
- Full-Time
- EXPERTISE
- Medical Device RA/QA, Quality Assurance
- SALARY TYPE
- Hourly
- SALARY
- Negotiable
Job Title: Quality Assurance Consultant
Location: South England
Company Overview: We are a growing medical technology company focused on developing innovative solutions that improve patient outcomes. Our products are used in hospitals and healthcare facilities worldwide, and we are committed to maintaining the highest standards of quality and compliance.
Key Responsibilities:
- Provide expert guidance and support to the business on all matters relating to quality assurance and regulatory compliance for medical devices
- Ensure that all products comply with relevant regulatory requirements and industry standards (e.g. ISO 13485, 62304 and SaMD)
- Manage and maintain the company's Quality Management System, ensuring it is up-to-date and compliant with relevant regulations and standards
- Ensure that all internal and external audits are successfully completed, including liaising with regulatory bodies and certification organizations
- Develop and implement procedures for product quality control and assurance, including risk management, process validation, and product release
- Work collaboratively with cross-functional teams to ensure that all quality requirements are met throughout the product lifecycle
**Requirements**:
- Bachelor's degree in a related field (e.g. engineering, science, healthcare)
- Minimum of 5 years' experience in a quality assurance role within the medical device industry
- Strong understanding of relevant regulatory requirements and industry standards (e.g. ISO 13485, MDR)
- Proven track record of successful regulatory submissions and audits
- Experience in developing and maintaining a Quality Management System
- Excellent communication and interpersonal skills, with the ability to work collaboratively with cross-functional teams
- Strong problem-solving skills and attention to detail
- Must be eligible to work in the UK
If you are passionate about quality assurance and regulatory compliance within the medical device industry, and are looking for an exciting new opportunity, we encourage you to. We offer competitive compensation packages and a dynamic work environment.
Consultant
- Amal Radia
- +441293776644
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