Senior Quality Engineer (Medtech)

TL;DR

Senior Quality Engineer (Medtech): Supporting manufacturing operations at the Irvine Toledo site by leading NCMRs, DHR review, and CAPA execution with an accent on quality compliance and continuous improvement. Focus on designing and implementing quality improvements, optimizing inspection processes, and ensuring adherence to ISO 13485 and QSR 21 CFR 820 standards.

Location: Onsite in Irvine, California, USA

Salary: $96,800 – $145,200

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life.

What you will do

• Support manufacturing operations through NCMR, DHR review, and CAPA execution.
• Develop and maintain quality standards and protocols for processing materials.
• Design and implement inspection and testing mechanisms for product accuracy.
• Perform statistical analysis to assess product reliability and the cost of non-conforming materials.
• Collaborate with engineering, manufacturing, and supplier quality teams to ensure standards are met.
• Apply Lean Six Sigma principles to streamline manufacturing processes and enhance efficiency.

Requirements

• Baccalaureate degree with 4+ years of relevant experience, Master's with 2+ years, or PhD.
• Unrestricted U.S. work authorization required (sponsorship is not available for this level).
• Experience in quality assurance within a manufacturing environment.
• Ability to work onsite 5 days a week.

Nice to have

• Knowledge of ISO 13485 and QSR 21 CFR 820 requirements.
• Lean Six Sigma/DRM knowledge or certification.
• Experience developing and implementing Test Methods and Test Method Validations (TMVs).
• Prior experience in project management.

Culture & Benefits

• Comprehensive health, dental, and vision insurance including HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and short/long-term disability leave.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and global well-being program (Simple Steps).