Description: *** 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 fulfilment of regulatory commitments. The potential scope of products with regards to testing and inspection methods include 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 fulfilment 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.
Top 3 Must Have Skill Set
CAPA and non-conformance experience a must
Test Method Validation / Measurement Systems Analysis / GRR
Test Method Design and Development
VERY 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!
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.
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.
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 60601
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