Quality Engineer

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: Sr. Quality Engineer will lead a project focused on improving the quality and compliance of the Dispensing Implementation process. This role involves collaborating with the Dispensing Implementation teams to identify, document, and implement compliance-related improvements, ensuring the process aligns with regulatory standards and can pass an external regulatory inspection.
Responsibilities: Evaluate the Dispensing Implementation process against regulatory requirements such as CFR and international standards. Lead a cross-functional team to develop and execute a plan to enhance the process's compliance. Communicate weekly progress updates to Quality and SDS leadership teams. Ensure compliance with all service record documentation requirements. Adhere to Client Inspire Quality Processes and drive effective installation and implementation execution. Requirements: Strong knowledge of quality engineering principles, policies, and best practices. Expertise in regulatory requirements including CFR , , ISO , and ISO . + years of experience in a Quality role within FDA-regulated environments. Proven track record in quality/compliance improvement projects in FDA-regulated environments. Experience with medical device installation, especially with embedded software, is strongly preferred. Strong attention to detail, organizational skills, and the ability to manage multiple tasks efficiently. Excellent communication and interpersonal skills with the ability to work collaboratively across teams. Proficiency in Excel, Word, and general business systems. Quality Engineering Certification (, ASQ) is preferred.
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Location:
San Diego

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