Our client a high potential and well funded start up medical device company with a highly experienced management team with a highly successful track record are currently seeking a quality engineer to join their team. This role is intended for a candidate who has limited experience and wishes to grow and learn within a rich working environment. As a Quality Engineer, you will provide support in quality assurance, control, and manufacturing activities with a focus on continuous improvement of products and processes for in-house developed technology. You will support the execution of initiatives and projects to enhance quality performance within the business, ensuring compliance to regulation and standards.



Role/Responsibilities

• Lead quality system improvement initiatives and ensure maintenance of the quality system.
• Support supplier quality activities impacting daily operations.
• Work closely with R&D and Manufacturing to execute product and process verification and validation activities in accordance with quality system policies and practices.
• Execute quality risk management including hazard/failure mode effects analysis.
• Develop appropriate product inspection and process monitoring criteria and methods.
• Execute and track Design Control activities.
• Own and manage internal and supplier driven non-conformances and CAPAs, ensuring timely containment actions, corrections, root cause investigation, implementation of corrective actions, and closure.
• Monitor KPIs for tracking of process and/or product quality, perform analysis and interpret trends.
• A hybrid approach of working from home and in the office will be considered for this role in accordance with company policy.

• Degree in Engineering or Science discipline.
• Minimum of 2 years’ quality related experience in the medical device industry
• A hands-on mindset