Sector: Life Sciences
Consultant: Life Sciences Team
Salary: £40000 - £50000
Job Status: Permanent / Full Time
Title – Senior Quality Officer
Location – Oxfordshire
Hours – full time 40hrs, Office based
Salary – £40,000 – £50,000 per year
Responsibilities will include:
Supporting the Quality Assurance manager and working with all departments to ensure compliance to ISO13485 and maintaining accreditation.
Supporting the QA manager with internal Audits and liaise with external suppliers to address matters of quality or compliance.
Supporting the QA manager in dealing with Non-Conformances and CAPA’s
Provide support during and prior to Notified Body audits.
Devise and establish quality procedures, standards and specifications compliant with the ISO 9001:2015 standard which are lean with minimum administration.
Positively engage employees with quality and its control processes and procedures.
To ensure that we have a progressive and structured programme of future medical device development, adding value by increased efficiency and the accumulation of intellectual property
Skills and experience:
A minimum of 3 years’ experience working as a Quality officer. Experience of working in a Scientific company is essential. Must have knowledge of ISO 9001, 13485 and 14971.
A BSc in Biology or a similar subject.
Day to day knowledge and maintenance of electronic Quality Management Systems
Experience of developing and implementing the ISO 9001 quality management system and achieving formal accreditation/certification
Background in Regulatory Affairs + Medical Devices experience
Experience with medical device regulation in various markets such as US, China, Japan, Malaysia and Singapore.
Knowledge of CE marking, GLP, GMP, MDD 93/42/EC and IVDD 98/79/EC would also be useful.
A strong team player with the ability to engage, persuade, influence and negotiate with staff and managers.