Quality Engineer: Medical Device Process & Compliance

Applied Medical; Rancho Santa Margarita (CA); On-site; USD 71,000 - 75,000; Full time

Benefits offered by this job

Competitive pay

Comprehensive benefits

Education reimbursement

401(k) plan

Job summary

Applied Medical, a leading medical device company, seeks a Quality Engineer to support product quality, regulatory compliance, and manufacturing excellence in a regulated environment.

The role focuses on process validation, risk management, and documentation integrity across the product lifecycle, with collaboration across design, manufacturing, and quality teams to drive continuous improvement.

Qualifications

• Bachelor's degree in engineering or related technical field.
• Strong technical writing skills for SOPs and quality docs.
• Analytical, detail-oriented approach to quality and processes.

Responsibilities

• Review and approve DMR documents and IQ/OQ/PQ protocols and reports.
• Create and validate test methods for design verification and inspection testing.
• Document and review NCIRs and support CAPA and audits.
• Coordinate clean room maintenance and environmental monitoring programs.
• Develop SOPs and job aids; collaborate on risk and pFMEA with design/manufacturing.
• Perform experiments, apply statistics for sample sizes and confidence levels.
• Assist with training of new team members.

Skills

Quality Engineering

Regulatory Compliance

Documentation

Analytical Thinking

Cross-functional teamwork

Education

Bachelor's degree in engineering

Job description

Applied Medical, a leading medical device company, seeks a Quality Engineer to support product quality, regulatory compliance, and manufacturing excellence in a regulated environment.

The role focuses on process validation, risk management, and documentation integrity across the product lifecycle, with collaboration across design, manufacturing, and quality teams to drive continuous improvement.