Principal Operations Quality Engineer

What you'll do

• Develop, implement, and maintain quality standards, procedures, and protocols for manufacturing operations.
• Integrate quality requirements into products, processes, and operational controls in partnership with Engineering and Manufacturing teams.
• Create and oversee inspection, testing, and evaluation methods to verify product performance and equipment accuracy.
• Conduct root cause investigations, statistical analyses, and risk assessments to drive corrective and preventive actions.
• Ensure all quality documentation and records comply with internal procedures and regulatory requirements.
• Lead complex quality improvement initiatives regarding product reliability and process controls.
• Provide technical guidance and mentorship to quality professionals and cross-functional teams on strategic projects.

What we're looking for

• Bachelor's degree with 7+ years of experience, Master's with 5+ years, or PhD with 3+ years in quality, manufacturing, or engineering.
• Experience supporting quality engineering activities within a regulated manufacturing environment.
• Advanced knowledge of FDA Quality System requirements, ISO 13485, risk management, CAPA, and process validation (preferred).
• Expertise in conducting root cause investigations, statistical analyses, and risk assessments (preferred).
• Ability to make audit-defensible decisions regarding product nonconformances and manufacturing failures (preferred).
• Experience serving as a senior Quality Engineering representative during audits or regulatory inspections (preferred).
• ASQ Certified Quality Engineer, Certified Quality Auditor, Six Sigma Black Belt, or similar certification (preferred).
• Work authorization at the time of hire and for the duration of employment.