Senior Quality Engineer, Medical Devices – Hybrid (Irvine)

Kelly Science, Engineering, Technology & Telecom; Irvine (CA); Hybrid; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401K

Paid time off

Job summary

Kelly Science and Clinical FSP in Irvine, CA is seeking a Staff Quality Engineer for a hybrid role supporting a medical device client. You will lead quality system effectiveness, drive continuous improvement, guide risk-based decisions, and partner with cross-functional teams to meet regulatory obligations under ISO 13485, FDA 21 CFR Part 820, and MDSAP.

The position offers full benefits (medical, dental, vision, 401K) and paid time off.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, or related field.
• 4+ years in Medical Device or regulated healthcare industries.
• Experience leading quality/compliance initiatives.
• Experience supporting regulatory inspections and audits.

Responsibilities

• Lead strategic quality and compliance initiatives.
• Facilitate risk assessments and drive risk-based decisions.
• Analyze quality data and identify improvement opportunities.
• Support audits, inspections, and regulatory activities.
• Lead investigations, CAPAs, and continuous improvement programs.
• Manage cross-functional projects to ensure timely execution.
• Provide quality guidance to leadership and partners.

Skills

QMS knowledge

Regulatory awareness

Data analysis

Cross-functional leadership

Project management

Quality tools

Statistical analysis

Process mapping

Auditing

Communication skills

Education

Bachelor's degree in Engineering/Life Sciences/Quality

Tools

Minitab

Excel

JMP

Quality management software

Job description

Kelly Science and Clinical FSP in Irvine, CA is seeking a Staff Quality Engineer for a hybrid role supporting a medical device client. You will lead quality system effectiveness, drive continuous improvement, guide risk-based decisions, and partner with cross-functional teams to meet regulatory obligations under ISO 13485, FDA 21 CFR Part 820, and MDSAP.

The position offers full benefits (medical, dental, vision, 401K) and paid time off.