Quality Engineer

Your JobThe main focus of the role is primarily to ensure the quality standards are met. In this role you will form part of a cross functional team involved in the day-to-day activities and other QMS activities as needed. You will be working in both manufacturing & non-manufacturing (QMS process based) setting. You will also have some supervisory responsibility, including completing probation and annual performance reviews and providing direct coaching, guidance and support.Our TeamReporting to the Site Quality Lead you will be part of a dedicated team of engineers and technicians within the Quality department.What You Will DoBe part of a cross functional team involved in the day-to-day QMS activities. Support the investigation, root cause, corrective action in relation to all non conformities and CAPA activities. Work closely with Production in relation to new day to day quality issues. Perform and provide support to validations, metrology, document control, change control and auditing as required. Interact directly with vendors and customers. Be part of improvement activities. Promote a positive environment where achievements and accountabilities are acknowledged and open two-way communication encouraged. Provide input from a quality perspective to product & process risk assessments, pFMEA. Set up/amendment to routines and inspection plans in SAP. Liaise with other departments as required as part of day-to-day activities. Who You Are (Basic Qualifications)Bachelor's degree or equivalent in Quality, Engineering, Science or related discipline Good working knowledge of ISO 9001 Past working experience, preferably in a medical device or manufacturing environment Excellent attention to detail in verbal & written communication, with a proven technical protocol & report writing background MS Office proficient What Will Put You AheadFDA experience would be preferred, but not essential Experience with SAP will be beneficial. Good working knowledge of ISO 13485 Previous experience in a medical device setting.Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.#LI-JO2