Senior Quality Systems Specialist
Salary: £40,000.00 to £50,000.00 /year
Job Type: Full-time, Permanent
Salary: £40,000.00 to £50,000.00 /year
Job Types: Full-time
Ultromics is an innovative start-up imaging diagnostics company spun out of the University of Oxford. Ultromics is an inter-disciplinary team, setting new standards for diagnostic imaging solutions powered by artificial intelligence for cardiovascular disease. We have developed an echocardiography analysis platform called EchoGo, that aims to reduce diagnostic errors by 75%, which would significantly increase accuracy for diagnosing coronary artery disease in one of the most widely used diagnostic tests. The company has raised £12 million to take this technology to market in the US and UK.
The Senior Quality Systems Specialist will implement and maintain the quality program and associated procedures to ensure overall compliance with ISO 13485, FDA Quality Standard Regulations (21 CFR Part 820) and other local, state, and international regulations and laws, associated with maintaining a marketed medical device. The role holder will report to the QA/RA Manager.
Key Duties & Responsibilities
- Assist in ensuring compliance with the organization’s policies and all applicable national and international quality standards and regulations (i.e. ISO 13485, FDA 21 CFR Part 820).
- Assist in the development and maintenance of the document control process.
- Ensure complaints are investigated and resolved in a timely manner.
- Track CAPAs to ensure appropriate verification, implementation and follow-up on corrective actions.
- Develop and maintain QA standard operating procedures (SOP) and review SOPs generated by other departments.
- Conduct internal and external audits of the quality system.
- Collect information related to key QMS indicators and performance, including creation of periodic reports for management.
- Present at management review meetings information regarding the functioning of and impact of the quality system.
- Maintain knowledge of new developments in regulatory and quality standards that would have an impact on the operations and business of Ultromics.
- Develop and perform QMS training for employees.
- Identify and recommend opportunities for Improvement.
This list of duties is not exhaustive and the post holder may be asked to carry out other duties through discussion with their line manager.
- Strong knowledge of ISO standards and FDA regulations/guidance as they apply to medical devices.
- Previous experience with management of Quality System documentation.
- Previous experience in managing and investigating complaints and CAPAs.
- Ability to effectively manage multiple and changing priorities.
- Ability to work in a high paced environment.
- Ability to collaborate to achieve objectives, problem-solve, and meet timelines.
- Understanding of the software development lifecycle
- Experience in handling and coordinating responses to FDA and ISO inspections.
- Strong interpersonal skills including a proven track record of building and maintaining effective working relationships with teams and industry partners.
- Strong communication (written and verbal) and computer skills.
- Bachelor’s degree in science/engineering and/or 3-5 years of experience in quality systems/quality assurance in the medical device industry.
We are an equal opportunities employer and positively encourage applications from suitably qualified and eligible candidates. Entry into employment and progression within employment will be determined only by personal merit and the application of criteria which are related to the duties of each particular post and the relevant salary structure. In all cases, ability to perform the job will be the primary consideration. No applicant or member of staff shall be discriminated against because of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity, race, religion or belief, sex, or sexual orientation.
If you’re selected for an interview and have special requirements due to a disability please let us know so that we can make any necessary adjustments.
Information Security Compliance
By applying for this position, you are confirming that you will be required to comply with Ultromics’ Information Security Policies if you are hired for this role.
How to Apply
Fill in the form below, making sure you attach the following:
1) Your CV
2) A document detailing how you meet the role requirements and explaining why you are applying for the role.
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