Senior Quality Assurance Officer
Salary c. £30,000 - £40,000
Title: Senior Quality Assurance Officer
Salary: c. £30,000 – £40,000
Are you an individual with working experience within Medical Device/IVD Quality Assurance? A fantastic new opportunity is available within a rapidly expanding diagnostics company based in Newcastle-Upon-Tyne! The company are looking to hire an individual who shares their passion for the advancement of diagnostics.
As a Senior Quality Assurance Officer, you will be responsible for the management of the Quality Management Systems and their crucial functions involving CAPA, Non-conformance and validation support. As well as experience within, and an up-to-date working knowledge of relevant Quality Standards to Medical Device/IVD industries such as ISO 13485 and 21 CFR 820. You will be a mentor and an experienced and knowledgeable point of contact for other QA staff, assisting with quality responsibilities across multiple site projects including design and supplier QA.
- Management of the Quality Management System via:
- Establishment and maintenance, complying to ISO 13485 and 21 CFR 820.
- Planning, support, and direct involvement in all audits.
- Support with CAPA, Non-conformances, validation, batch record approval, and training requirements.
- Further document control and record management.
- Direct involvement in supplier quality standards, agreements, and metrics. As well as supplier audits and checking the quality of incoming materials.
- Represent QA during Design Control and Risk Management for new product development and device change initiatives.
- Support design QA with cross-site projects.
- Use knowledge and experience to identify and solve complex problems and risks within Quality Systems.
- Use company systems regularly to continually improve QA functions.
- Work closely with QRA management to develop objectives, as well as working with internal and external stakeholders.
- Maintain your working knowledge of all relevant regulations and QA requirements that affect the business.
- Additional Health and Safety Responsibilities:
Provide a healthy and safe workplace for employees, contractors, and visitors.
• Work with EHS Manager to implement policies, procedures, and support improvements via Support of EHS framework.
• Support best practice safety performance levels and ensure business complies with all relevant EHS regulations.
• Be actively involved in Workplace Inspections and Near Miss and Incident reporting. Ensure safety performance is included in annual staff reviews. Reviewal and discussion of statistical data (near misses, incident reports, etc) in monthly management meetings.
- Hold a relevant degree in science, medical or technical field and experience with increasing responsibility in medical device/IVD Quality Assurance.
- Must have requisite training or certification in medical device Quality Assurance through on-the-job training, seminars, training. Relevant certifications preferred.
- Experience with quality system audits. As well as an extensive knowledge of medical device quality systems including but not limited to 21 CFR 820 and ISO 13485. Effective working knowledge of medical device design controls and risk management.
- Experience in supplier quality, manufacturing, supplier risk management, design transfer processes.
- Ability to apply practical QA experience and knowledge to one or more area(s) of quality assurance. Such as the ability to identify, analyse and mitigate risk (e.g. product, material, compliance, supply).
- Ability to work independently with initiative.
- Effective organisational and time management skills.
- Great communication skills. Ability to explain difficult or sensitive information, as well as the ability to use appropriate software tools to develop and edit documents, procedures, reports.
If you are interested in knowing more or applying contact: [email protected]