these roles will start out remote due to COVID and then will go to onsite, M-F Provide quality oversight with regards to the development and lifecycle management of test and inspection methods and fulfillment of regulatory commitments. Potential scope of products with regards to test and inspection methods includes a wide range of devices, raw material components, and constituent parts, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems. The qualified candidate will both lead and/or support technical teams to ensure successful method development or remediation and/or fulfillment of regulatory commitments. The role of the Senior Quality Engineer is to provide quality oversight to one or more cross-functional teams to utilize technologies and methodologies that support short-cycle robust development, accelerated compliance efforts, and/or remediation/improvement opportunities.Responsibilities: Work cross-functionally and globally with individuals and project teams within Final Product Technologies Quality and the Final Product Technologies Engineering groups and their stakeholders in Marketing, Operations, and Development; Ensure compliance to design controls and fulfillment of user needs during test or inspection method development or design changes, including proper and compliant integration of different subsystems as required. – Provide quality oversight and guidance regarding the development of process control plans and implementation of process improvements/changes. – Work with cross-functional teams to develop, qualify, and transfer physical test or inspection methods. - Provide comprehensive quality guidance and advice to counterparts and stakeholders.Major contributions to or the leadership of projects from development through the 510k and PMA approval process. - Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification/validation, DOE/SPC process optimization & validation (IQ, OQ, PQ), P/DFMEA. - Product design/development (design control) from concept to post product launch for Europe (EMEA/CE Mark) & US (FDA/PMA/510k) submissions. - Experience in test or inspection method design and development - Small scale device assembly and/or benchtop testing experience. – Experience with Automated Test Equipment (ATE). – Experience with regard to Measurement Systems Analysis/GRR principles, including study design/execution/troubleshooting – Strong critical thinking, problem solving, risk assessment, and risk management skills. - Must be capable of working on multiple projects in a deadline driven environment.Familiarity with the following standards: o Quality System Regulation – 21CFR820; Risk Management – EN/ISO 14971; EU Medical Device requirements – Council Directive 93/42/EEC; Medical Electrical Equipment – EN/ISO 60601VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, Quality Engineering, AND/OR Systems/Software Engineering background need apply and will be considered!
BS or BE in Engineering and previous experience in the medical device and/or pharmaceutical industries - 8 years current experience with engineering processes/procedures and quality tools. -
Top 3 Must Have Skill Sets:
CAPA and non conformance experience a mustTest Method Validation / Measurement Systems Analysis / GRRTest Method Design and DevelopmentDesign Controls is preferred