Sr. Quality Engineer - Medical Manufacturing

Location: Baldwin Park, California, United States; onsite

Salary: $95,000–$115,000 annually, depending on skills, experience, and qualifications.

Company

hirify.global operates in medical device manufacturing.

What you will do

• Serve as a site subject matter expert on ISO requirements, standardization, compliance, and continuous improvement.
• Apply Minitab, Six Sigma, SPC, DOE, and other statistical tools to analyze data, improve process capability, and reduce risk.
• Lead quality planning, sampling plans, process controls, early launch monitoring, NPI quality, and design transfer activities.
• Manage CAPA review activities and provide compliant solutions and issue summaries to senior management.
• Lead and mentor Quality Engineers and Technicians while supporting production, process improvement, and customer satisfaction.
• Coordinate supplier quality activities, internal and external audits, inspections, and change-related assessments.

Requirements

• Bachelor’s degree in Engineering, Chemistry, Biology, or a related science or technical field.
• 8+ years of quality engineering experience in the medical device industry.
• Advanced knowledge of ISO 13485, ISO 14001, ISO 14971, GMP, 21 CFR 820, and MDSAP requirements.
• Experience with DOE, FMEA, Control Plans, MSA, SPC, GD&T, fixturing, root cause analysis, CAPA, and formal problem-solving methods.
• Demonstrated ability to lead audits and inspections, address findings, and manage design control, validation, and verification processes.

Nice to have

• 5+ years of injection molding manufacturing experience or equivalent.
• Project management experience.
• CQE, CQA, RAC, or Lean/Six Sigma certification.

Culture & Benefits

• Full-time employment.
• Commitment to diversity, inclusion, and equal employment opportunity.