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This role involves implementing and maintaining quality systems aligned with regulatory requirements, ensuring compliance with ISO 9001 and GMP standards. Responsibilities include developing team capabilities, overseeing audits, driving process improvements, and maintaining regulatory compliance across the organization.
The Senior Quality Manager ensures compliance with regulatory requirements, ISO standards, and GMP for all products designed, manufactured, and distributed at the Norwood site. They lead strategic enhancements to the Quality Management System, oversee audits and inspections, and act as the site's Quality Management Representative.
The Manufacturing Engineer will develop and implement efficient manufacturing processes and methods while coordinating the launch of new or revised products in a medical device environment. The role involves designing production processes, troubleshooting mechanical issues, and training production personnel to ensure quality and compliance with specifications.
This company is seeking a Software Quality Design Engineer to oversee quality engineering tasks for pharmaceutical manufacturing, including risk management, documentation, and CAPA management. The ideal candidate will have 2-5 years of experience in medical device software quality, expertise in risk management (ISO 14971, FMEA), and a background in Agile methodologies. This is a fully onsite position in Middlesex County, MA.
A client is looking for a Devops Security Engineer who will collaborate with the DevOps team to create and manage a comprehensive DevSecOps framework that integrates security tools into the CI/CD workflows, enhancing the developer experience. They will promote a security-first mindset within the development team by advocating for secure coding practices and offering guidance on secure development methodologies.
The Senior Software Quality Engineer is responsible for ensuring product quality during the software development life cycle, involving design, verification, and validation processes. Candidates should have at least eight years of experience in quality engineering within regulated industries, with knowledge of ISO standards and the ability to conduct risk management and internal audits.
This C#/.NET Software Developer role is in Carmel Indiana. The Purpose of the Software Developer Senior is to work closely with the Product Managers, Solution Architects, Business Analyst, and Quality Assurance to produce high quality enterprise level web applications in software as a service model.
This position is a chance for a talented and ambitious Software Engineer to join a revolutionary medical device organization in Marlborough, MA and make a real impact on patient care around the world.
In this role, you will oversee and implement quality control processes to ensure the integrity and safety of our products. Your primary responsibilities will include developing and enforcing quality standards, performing regular audits and inspections, and working with cross-functional teams to resolve quality issues. Additionally, you will be involved in continuous improvement initiatives to optimize efficiency and effectiveness.
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