Jobs in Strathpeffer, highlands

About the RoleOur Client is seeking an experienced and highly skilled Senior Quality Engineer to join our dynamic team. This role is critical in ensuring compliance with ISO 13485 / MDSAP standards and regulatory requirements for medical devices and in-vitro diagnostics (IVD). You will play a key role in maintaining quality and performance standards across the company, working collaboratively to support design, development, manufacturing, and post-market surveillance activities.You will be responsible for ensuring that design and development and manufacturing processes are conducted in strict compliance with our ISO 13485-certified Quality Management System (QMS). Your expertise in quality documentation, risk management, and regulatory compliance will drive excellence in project execution.This is an exciting opportunity to make a meaningful impact in a rapidly growing and innovative medical technology company, with strong potential for career growth.Key ResponsibilitiesDevelop, maintain, and own technical documentation to ensure compliance with regulatory and quality standards.Help to transition GRX's current hybrid QMS to a full eQMS system - help to provide training to employees and be SME on the system.Support and manage design control processes for Class II / III medical devices and Class C IVDs, ensuring regulatory compliance from concept to commercialization.Assist with regulatory submissions and support market authorization applications.Pr...