We have a current opportunity for a Quality Engineer at a Med Device company based in SoCal on a hybrid basis.
In a cooperative manner, this quality engineer will actively promote compliance and quality in design and development. The potential to join a creative and effective team and have an early impact on design and development presented by this role is exciting.
You will actively support design controls, a design history file, risk management, design verification and process validation protocols, testing, and other team activities as a key team member. The Operations and R&D groups are also given technical support by this job. Additionally, this individual will actively contribute to the creation and upkeep of the quality management system and assure QMS compliance.
responsibilities, expertise, and practical experience
- Support design controls outputs
- Help with test and inspection method creation and validation.
- DHF, design verification documentation, and risk management paperwork are just a few examples of the deliverables that support design controls.
- supports duties relating to incoming, in-process, and final inspection and test.
- supports the creation and upkeep of the risk management file and any associated deliverables, like the hazard analysis and FMEA.
- Create technical documentation to support design control activities and regulatory submissions, such as production instructions, test procedures, protocols, and reports.
- Give direction on relevant norms and standards and make it possible for designs to incorporate them.
- Examine the design control records, such as requirements, specifications, test plans, protocols, and reports, among others.
- Create procedures and methods for quality inspection in production and design.
- Give recurrent updates on the progress of the project.
- exposure to or experience with design controls and risk management for interventions in cardiology and/or medical devices.
- proficiency with and/or experience to Design Verification, including statistical methods and data analysis, Test Method Validation, and Process Validation.
- Clinical research, biocompatibility and sterilization validation, software development life cycle (62304), product labeling, and electronics testing and reliability are some of the areas that exposure to one or more of these topics is advisable.
- It is preferred that candidates have experience dealing with suppliers and have a solid grasp of their capabilities, materials, and fabrication techniques.
- Working understanding of medical device laws, such as the FDA QSR, ISO 13485, EU MDR, etc.
Education:
-B.S. or higher in Biomedical, Electrical, Mechanical or Systems Engineering or comparable relevant work experience.
-Three or more years of experience working as a quality engineer. Experience with electromechanical and/or interventional cardiology devices in the medical device business is preferred.
