Quality Engineer

Job Description:
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 820.200 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 21 CFR 210, 211, ISO 13485, and ISO 14971.
• 10+ 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 (e.g., ASQ) is preferred.