Quality Engineer: Medical Device Process & Compliance

Applied Medical; Rancho Santa Margarita (CA); Vor Ort; USD 71.000 - 75.000; Vollzeit

Benefits dieser Stelle

Competitive pay

Comprehensive benefits

Education reimbursement

401(k) plan

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Engineering

Regulatory Compliance

Documentation

Analytical Thinking

Cross-functional teamwork

Ausbildung

Bachelor's degree in engineering

Jobbeschreibung

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.