#x. A 0; The Quality Engineer is the subject matter expert for Software as a medical device SAMD and/or software as an accessory/component to a medical device, and ensures the software is compliant with all regulations. This role oversees implementation of the project quality management plan s and product plans of the organization. He/ She helps to ensure the quality, compliance, and integrity of GXP systems used in the development, manufacturing, and distribution of medical devices / In vitro d... more details
Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a direct hire opportunity to work as a Quality Engineer located in Warren, NJ.
Shift: Monday-Friday, first shift; hybrid (3-4 days/week onsite)
Pay: $90k max (dependent on experience)
Job Overview:
The Quality Engineer is the subject matter expert for Software as a medical device SAMD and/or software as an accessory/component to a medical device, and ensures the software is compliant with all regulations. This role oversees implementation of the project quality management plan s and product plans of the organization. He/She helps to ensure the quality, compliance, and integrity of GXP systems used in the development, manufacturing, and distribution of medical devices / In vitro devices IVD . The role also manages projects from concept to completion; creates and manages project plan, work cross functionally to ensure completion, and ensure adequate training to impacted areas. He/She works effectively with stakeholders to ensure alignment with business objectives, correct prioritization, and successful project delivery and assists with product and process validations, including protocol and report review.
Key Accountabilities:
Quality reviewer of software revision documentation, such as user acceptance testing and software testing/qualification.
Work with software team during design updates.
Ability to lead a cross-functional core team in successfully delivering to system-based projects and process improvements.
Collaborate cross-functionally to create and execute project plans scope, schedule, staffing plans, quality, risk management, budget, and procurement and revise them appropriately to meet changing needs and requirements.
Ensure that upgrades to medical device reagents and software are made in compliance with all applicable regulations.
Support quality and regulatory teams in creating/revising technical documentation related to IVDs reagents and software and support deliverables required to meet country registration requirements.
Monitor, analyze, and report on GXP system metrics and identify trends and areas for improvement.
Support risk management practices and concepts and applies knowledge to manufacturing operations and software development.
Support risk management program associated with commercial and development medical devices.
Engage in the development and improvement of the internal manufacturing processes for existing and new products.
Ability to simultaneously manage commercial and development projects.
Update and maintain Design History Files / Technical documentation as needed.
Including editing and review of impact and risk assessments for design, process, and risk control activities. Ensure integration of product regulatory requirements into product specifications and technical documentation.
Partner with internal functional areas as part of the change control process.
Support CAPAs and change control associated with product improvements.
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