A medical device company is looking for a QA Associate to join its team on a 6 month contract. You will work as part of a team supporting and monitoring all areas of the Quality Management System. You must have experience of working in a Quality Environment within medical devices or other regulated industry to apply for this role.
- Maintain monitoring and measuring of Quality Systems processes, including key performance indicators, Quality objectives, CAPA and audit findings for input into Management Review. Maintain and improve the on-site QMS, providing data trends and reporting Quality KPI's to Senior Management to ensure continued GMP compliance of manufactured products.
- Act as a point of escalation for Internal Customers regarding processes and products, with an understanding of the end to end process to fulfil the QMS requirements in a fair and professional manner
- Provide support in the preparation and distribution of the QA Monthly and other departmental reports.
- Identify and escalate potential risks and operational issues as appropriate.
- Identifying, understanding, investigating and resolving routine issues within area of responsibility.
- Internal auditor.
- External audit support.
- Assist in developing and conducting internal training programs to promote the awareness of the importance of regulatory issues to other departments, as appropriate.
- Plan workflow through the department to ensure timely delivery of all projects.
- Provide support to the management compiling the management review presentation, minute taking, reporting and progressing follow up actions.
- Creation and maintenance of quality databases.
- Provide training support.
- Support QA team with administration tasks.
- Participate in training and briefing activities that will ensure ongoing awareness of changes in products, services and business unit policies and procedures, to minimize risk and provide information that is accurate, fair and tailored to Internal Customer needs.
- Lead / participate in multi-discipline teams engaged in quality projects and/or investigations
- Any other duties as directed by QA management.
- Understanding of quality and experience of working in a Quality Environment within a regulated industry.
- Clear and confident communication skills with fine attention to detail.
- Strong understanding of continuous improvement.
- Computer literate, with intermediate skills in the use of Word, Excel, PowerPoint, Visio and Outlook, with knowledge of relational database systems.
- Report / presenting writing skills.
- Motivated with good interpersonal and written communication skills.
- Flexible approach to work.
- Enquiring, methodical, organized and able to use initiative.
- Able to move between sites.
- Ability to effectively work alone or part of a team.
- Ability to work under pressure and to tight deadlines.
- Knowledge of Agile.
- Process knowledge of QA and / or manufacturing.
- Practical experience in Quality Management Systems within the Medical Devices industry or related industries. Minimum three years' experience.
- Lens Measurement.
- Agile knowledge and experience
You must be eligible to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Reference: 6683
- Posted: 6th November 2020
- Expires: 4th December 2020