Job Description
**Quality Engineer Position at Integer** Integer is seeking a Quality Engineer to maintain and improve quality systems, monitor production processes, and ensure compliance with regulatory standards. Maintaining Quality Systems and Compliance ===================================== Integer's Quality Engineer will be responsible for ensuring continued compliance with regulatory standards, including ISO 13485, MDSAP, and ISO 14000. This includes: • Monitoring production processes for compliance with implemented process controls • Trend analysis of data from process controls to identify potential improvements • Reviewing and proposing changes to sampling plans based on trend analysis and changes to the system • Ensuring continued compliance with Quality Plans and Risk Management Documents Key Responsibilities ================== The Quality Engineer will be responsible for: • Ensuring that quality product is shipped to customers • Providing trend analysis of data from process controls • Identifying areas for improvement and proposing changes to senior management • Reviewing and proposing changes to sampling plans • Supporting NCR meetings to handle internal and customer concerns • Reviewing and ensuring approval of documents, including Validations, Change Requests, and Non Conformance Reports Requirements ------------ The ideal candidate will have: • A degree with strong engineering, science, or quantitative content • Experience in analysis and reporting using Minitab or equivalent • Good communication and leadership skills • Ability to train and lead where required • Knowledge of Statistical and Quality Improvement methods