Quality engineer / manager - medical device manufacturing

The purpose of this role is to support the continued development, implementation and maintenance of company-wide quality management procedures, processes and quality improvement practices. Furthermore, this role will have a requirement to assist in Health, Safety and Environmental policies and processes.

Responsibilities:

·Support in the development, implementation, maintenance and control of on-going (or future) compliance to all certifications and standards relevant to the company. These will include as a minimum: ISO13485 (including EU MDR and UK MDR), ISO9001 and ISO14001.

·Actively support in the preparation and delivery of external QMS audits and assessments across all sites.

·Participation in the ongoing internal QMS auditing schedule.

·Key driver for NC and CAPA activities with both internal and external customers.

·Day-to-day management of QMS document control and associated QMS reports and trending.

·Generation and monitoring of data streams and analysis to support QMS maintenance and inform decision making across business.

·Support in maintaining and updating technical file documentation where necessary.

·Work alongside internal customers to support in on-going compliance to internal QMS and external standard/regulation requirements.

Provide ongoing support, training, facilitation, SME knowledge and tools across projects and departments – inclusive of R&D function.

Essential Requirements:

·Excellent analytical, communication and influencing skills.

·Excellent written, computing and verbal skills.

·Degree qualified (or with work-based equivalent experience) within a scientific or engineering discipline.

·Team player with the ability to work independently and demonstrate initiative.

·Experience in working within a highly regulated industry.

·Driven individual with the desire for continued professional development.

·Active involvement within NC/CAPA processes.

Desirable Requirements:

·Prior experience working with ISO13485 (Class II devices) and within a manufacturing environment.

·Previous experience of working within HSE organisations.

·Experience and/or qualification within internal/external auditing.

Knowledge of business operational tools (e.g. 6s, Lean, CI, Project Management, TQM) and data analysis (e.g. SPC, Pareto, Ishikawa)