Principal Quality Engineer

United Pharma; California (MO); On-site; USD 140,000 - 200,000; Full time

Job summary

United Pharma seeks an experienced Principal Quality Engineer to provide technical leadership across product development, manufacturing, process validation, and quality systems in FDA-regulated environments.

You will drive continuous improvement, lead risk management, investigations, validation activities, and audits, partnering with cross-functional teams to ensure compliant, high-quality medical devices throughout the lifecycle.

Qualifications

• 10+ years of Quality Engineering experience in the medical device industry.
• Experience in FDA-regulated environments.
• Strong quality systems, audits, CAPA and compliance.

Responsibilities

• Lead quality engineering activities across product development, manufacturing, and post-market support.
• Lead IQ/OQ/PQ, process validation, and continued process verification.
• Drive root cause investigations, CAPA, nonconformance, and deviation activities.
• Lead FMEA, hazard analysis, risk assessments, and risk-benefit evaluations.
• Develop quality plans, control plans, inspection strategies, and process monitoring approaches.
• Analyze quality and process data to identify trends and drive continuous improvement.
• Partner with Manufacturing, R&D, Supply Chain, Regulatory, and Operations teams to resolve quality issues.
• Support FDA, ISO, customer, supplier, and internal audits.

Skills

Quality Engineering

FDA-regulated

ISO 13485

CAPA

Risk management

FMEA

Process validation

Continuous improvement

Data analysis

Education

Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical field

Job description

We are seeking an experienced Principal Quality Engineer to provide technical leadership across product development, manufacturing, process validation, and quality systems in an FDA-regulated, ISO 13485 environment. This role will lead complex quality initiatives, support cross-functional projects, drive continuous improvement, and provide expertise in risk management, investigations, validation, and compliance.

Key Responsibilities:

• Lead Quality Engineering activities for product development, design transfer, manufacturing, and post-market support.
• Support new product introductions, process changes, and manufacturing transfers.
• Lead IQ/OQ/PQ, process validation, and continued process verification activities.
• Drive root cause investigations, CAPA, nonconformance, and deviation activities.
• Lead FMEA, hazard analysis, risk assessments, and risk-benefit evaluations.
• Develop quality plans, control plans, inspection strategies, and process monitoring approaches.
• Analyze quality and process data to identify trends and drive continuous improvement.
• Partner with Manufacturing, R&D, Supply Chain, Regulatory, and Operations teams to resolve quality issues.
• Support FDA, ISO, customer, supplier, and internal audits.

Skills & Qualifications:

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical field.
• 10+ years of Quality Engineering experience, preferably in the medical device industry.
• Strong experience in FDA-regulated and ISO 13485-certified environments.
• Proven experience supporting manufacturing, product development, validation, and quality systems.
• Experience leading complex quality projects and cross-functional initiatives.
• Strong knowledge of CAPA, risk management, FMEA, process validation, SPC, audits, and continuous improvement.