Quality Engineer 3

Roles & Responsibilities

• Evaluate the Dispensing Implementation process for compliance with CFR 820.200 and international regulatory standards.
• Lead a cross-functional effort to develop and implement a plan to improve the compliance state of the process.
• Provide weekly status updates to the Quality and SDS leadership teams.
• Ensure compliance with all service record documentation requirements.
• Adhere to Inspire Quality Processes.
• Drive effective and efficient execution of installation and implementation processes.

Experience Required

• Minimum 10 years’ experience in a Quality role within FDA-regulated environments.
• Proven experience in quality requirements for medical device installation.
• Extensive history of completing quality/compliance improvement projects in FDA-regulated environments.
• Strong experience with installation of medical devices, particularly those with embedded software (preferred).

Skills & Certifications

• Strong knowledge of quality engineering principles, policies, and best practices.
• Proficiency in Quality Engineering tools like Sampling Plans, Root Cause Analysis, and Statistical Analysis.
  Ability to collaborate across functions and teams to drive compliance improvements.
• Excellent verbal communication and interpersonal skills.
• Strong organizational skills, attention to detail, and ability to multi-task efficiently.
• Proficiency in Microsoft Excel, Word, and other business systems.

Eligibilities & qualifications

• Bachelor\'s degree in a relevant engineering field.
• Quality Engineering Certification (ASQ) or equivalent (preferred).
• Demonstrated ability to work independently and proactively.
• Ability to act as a resource for colleagues with less experience and mentor them effectively.