Quality Assurance Associate
Salary/ Package:
- £25,000 - £30,000 p.a. depending on experience and qualifications.
- Pension
- 20 days annual leave, plus Bank Holidays.
- Death In Service Benefit.
- Free on-site parking.
Location: Worcester
Schedule: Monday - Friday (9.00am - 5.00pm).
Reports to: RA/QA Director
Company Profile:
Our client is a medical manufacturer, with dedication to the highest quality manufacturing and industry leading clinical performance.
Position Overview:
To create regulatory documentation to support the company's medical devices and to help maintain the QMS, and by working with others within the business, improve its efficacy. You will also be able to provide appropriate input during external audits.
Key Responsibilities:
- Establishment of post-market surveillance and post-market clinical follow-up plans.
- Completion of post-market surveillance reports including Periodic Safety Update Reports (PSURs) and Summaries of Safety and Clinical Performance (SSCPs).
Management of clinical data collection from a variety of sources including:
- Direct feedback from user surgeons.
- Customer complaints.
- Patient Reported Outcome Measures (PROMs).
- Product information from joint registries.
- Vigilance databases.
- Published clinical literature.
- Assist in activities of Clinical Research Organisations (CROs) during clinical investigations as required.
- Input into Clinical Evaluation Reports (CERs).
- Input into internal product reviews.
- Input into vigilance reporting to regulatory authorities.
- Input into technical file documentation relating to clinical performance and associated risks.
Assist in the management of the QMS as required by the QA/RA Manager including:
- Providing input into customer complaint investigations.
- Providing input into corrective and preventive actions.
- Conducting internal audits.
- Maintaining SOPs and other QMS documents.
- Development and implementation of an eQMS.
Measuring and reporting:
- Agree priorities and standards with the RA/QA Director.
- Assist in the management of all PMS and QMS processes.
Working Relationships:
- Effective working relationships are an essential part of daily working life.
- This role requires the job holder to be a strong team player to ensure all targets are achieved.
Troubleshooting:
- As problem areas for PMS and QMS are identified you must bring these to the attention of the RA/QA Director and help to prioritise and address these areas and assist in the planned changes quickly and effectively.
Financial analysis:
- Assist in the management of agreed budget, promote requirements for additional funding where they can increase the customer recommendation ratings and increase overall business performance.
- Report your expenditure as required to the QA/RA Director.
Planning:
- Work with the QA/RA Director along with the senior management to drive continual improvement in people, technology, processes, service and product design and build.
- Ensure that poor performance is not tolerated and is remedied via support, training or disciplinary action as appropriate.
Training:
- Participate as required in continual upskilling through evaluation, development and training.
Day to day management:
- Work to continually improve your efficiency and effectiveness. In addition, ensure that you contribute to a positive team culture.
- Specific tasks: (not an exclusive list, but indicative) working under the direction of the QA/RA Director.
- Work in accordance with Company policies and procedures.
- Comply with responsibilities as laid down in the Group's Health & Safety Policy to ensure a safe environment within the department.
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