Quality Engineering Lead – Regulated Med Device

Katalyst-Healthcares-; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

JobDiva, Inc. seeks an experienced Lead Quality Engineer to provide technical leadership for quality activities in a regulated manufacturing environment, including validation, risk management, CAPA, nonconformance investigations, supplier quality, and new product development.

The role requires leading QMS compliance with FDA, ISO 13485, GMP, and collaborating with R&D, Manufacturing, Regulatory, and Supply Chain to drive improvements and mentor junior engineers.

Qualifications

• Bachelor's degree in engineering or related field required.
• 7+ years of Quality Engineering experience in regulated environments.
• Strong knowledge of QMS and regulatory requirements.
• Experience with CAPA and risk management.
• Hands-on PFMEA/DFMEA, SPC, Gage R&R.
• Cross-functional collaboration and communication skills.
• Experience leading validation and design transfer.

Responsibilities

• Lead and provide technical direction for Quality Engineering activities across manufacturing and product development.
• Develop, implement, and maintain quality plans, procedures, and engineering controls.
• Lead CAPA, nonconformance, deviation, complaint, and root cause investigations.
• Support and lead process validation, equipment qualification, and test method validation activities.
• Develop and review PFMEA, DFMEA, risk assessments, control plans, and inspection plans.
• Support Design Controls, Verification & Validation (V&V), NPI, and Design Transfer activities.
• Lead continuous improvement initiatives using Lean, Six Sigma, SPC, DOE, and statistical analysis.
• Monitor process capability, quality metrics, defects, and trends to identify improvement opportunities.
• Provide quality engineering support for manufacturing process development and sustaining engineering.
• Lead supplier quality activities, including supplier qualification, audits, corrective actions, and performance improvement.
• Ensure compliance with FDA regulations, ISO 13485, GMP, and applicable quality standards.
• Support internal, supplier, and regulatory audits.
• Review and approve quality and validation documentation.
• Collaborate with R&D, Manufacturing, Operations, Regulatory, Supply Chain, and Supplier Quality teams.
• Provide technical guidance, mentoring, and training to junior Quality Engineers.
• Lead moderately to highly complex quality projects and ensure delivery within established timelines.

Skills

Quality Engineering

CAPA

Risk Management

Process Validation

Lean Six Sigma

Root Cause Analysis

Regulatory Compliance

Project Management

Cross-functional Leadership

Mentoring

Education

Bachelor's degree in Engineering

Master's degree in Engineering or Quality-related discipline

Tools

Minitab

JMP

Job description

JobDiva, Inc. seeks an experienced Lead Quality Engineer to provide technical leadership for quality activities in a regulated manufacturing environment, including validation, risk management, CAPA, nonconformance investigations, supplier quality, and new product development.

The role requires leading QMS compliance with FDA, ISO 13485, GMP, and collaborating with R&D, Manufacturing, Regulatory, and Supply Chain to drive improvements and mentor junior engineers.