Exciting Medical Devices Development company seeks a highly self-motivated and enthusiastic Quality Officer.
About the role:
The Quality Officer is responsible for helping to maintain and improve the Quality Management System as part of the Quality team by identifying potential improvements and efficiencies and helping to develop, revise and implement Quality procedures and policies.
The Quality Officer will work with the Quality team to ensure products and design and development of future products are compliant with the requirements of ISO 13485 and ISO 14971 and IEC 62304.
Duties may include:
- Maintain a positive attitude and assist the QMS Manager to ensure deliverables are achieved within target timelines.
- Champion the highest level of quality & process and undertake training in order to develop.
- Work with the QMS Manager to identify and implement process improvements and efficiencies.
- Prepare, conduct and record internal system audits and participate in external vendor assurance audits.
- Perform regular supplier reviews.
- Maintain and administrate the electronic Quality Management System Q-Pulse.
- Effectively interact with Technical and Development teams to ensure research and development is performed in accordance with company procedures.
- Work with purchasing staff to establish Quality requirements from external suppliers.
- Ensure tests and procedures are properly understood, carried out, evaluated and documented and that modifications are investigated if necessary.
- Gather relevant data on QMS performance to facilitate statistical reporting where requested by the QMS Manager.
- Asset management and control including overseeing calibration and maintenance of assets as necessary.
- Investigate instances of non-conformance, propose possible suitable corrections, corrective and preventive actions. Review and advise on potential instances of non-conformance.
- Help to compile and maintain Medical Device Files, Technical Files and Device Master Records and product risk management files in preparation for Regulatory submissions in various markets globally with guidance from the VP QA/RA.
- QA review of both internal and contractor generated documentation relating to development, verification, validation as well as device manufacture and production records.
- Support the administration of a company-wide risk-based comprehensive training system.
- Help to design and deliver training sessions to ensure the understanding and compliance of all employees.
- Participate in and report validation of QMS-related computer software packages.
- Work within the rest of the Quality team to maintain focused, effective progression in line with Company Quality objectives.
- Support the Quality team by attending and providing feedback on training and mentoring activities.
- Perform other duties that may be required from time to time.
- Ability to manage multiple conflicting activities to deliver on time.
- Be receptive to delegated priorities and direct their own activities whilst supporting the team's activities.
Skills and experience:
- A highly motivated, organized, proactive and enthusiastic individual with a proven ability to work and motivate with utmost tact and diplomacy.
- A minimum of 2 years' experience in working within a Quality Management System, with some specific experience of working with medical devices is desirable but not essential.
- Experience of working with ISO 13485 and ISO 14971 is desirable but not essential.
- A degree in Life Sciences is essential.
- Outstanding teamwork and ability to interact with external and internal partners on fast-paced projects.
- Good sense of humour and ability to adapt to a changing environment following recent commercial launch of flagship product.
- Be eligible to work full time in the UK without restriction.