Quality Engineer – Medical Device

Kensington Consulting Ltd; San Antonio (TX); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Kensington Consulting Ltd in Texas is seeking a Quality Engineer for a medical device additive manufacturing role. You will own process validation (IQ/OQ/PQ), drive quality improvements, and ensure manufacturing processes are robust, compliant and scalable.

You will lead SPC and data analysis, investigate nonconformances, develop SOPs, and collaborate with QA, suppliers and leadership to shape quality systems as the site scales toward full production.

Qualifications

• Experience in regulated environments (medical device preferred).
• Strong background in process validation (IQ/OQ/PQ).
• Knowledge of ISO 13485 and FDA regulations.
• Experience with SPC, MSA, and root cause analysis.
• Ideally exposure to additive manufacturing or advanced manufacturing technologies.

Responsibilities

• Leading validation activities across manufacturing processes
• Driving process control using SPC and data analysis
• Investigating nonconformances and implementing corrective actions
• Developing SOPs and supporting regulatory documentation
• Working closely with QA, suppliers, and leadership

Skills

IQ/OQ/PQ

Statistical analysis

Regulatory compliance

Root cause analysis

Tools

SPC

MSA

Job description

Quality Engineer – Medical Device | Additive Manufacturing

Why This Role Stands Out

• Work at the cutting edge of additive manufacturing in medical devices
• High-impact role with real ownership of validation and process quality
• Opportunity to help build and shape quality systems from the ground up
• Close collaboration with senior leadership and external experts
• Clear progression as the site scales into full production

The Role

You’ll take ownership of process validation and manufacturing quality, ensuring advanced manufacturing processes are robust, compliant, and scalable.

This is a hands-on, technical role where you’ll lead IQ/OQ/PQ activities, drive process improvements, and act as the go-to expert for manufacturing quality.

What You’ll Be Doing

• Leading validation activities across manufacturing processes
• Driving process control using SPC and data analysis
• Investigating nonconformances and implementing corrective actions
• Developing SOPs and supporting regulatory documentation
• Working closely with QA, suppliers, and leadership

What We’re Looking For

• Quality Engineer with experience in regulated environments (medical device preferred)
• Strong background in process validation (IQ/OQ/PQ)
• Knowledge of ISO 13485 and FDA regulations
• Experience with SPC, MSA, and root cause analysis
• Ideally exposure to additive manufacturing or advanced manufacturing technologies

Why Apply?

This is a rare opportunity to step into a high-visibility role in a growing, advanced manufacturing environment, where your work will directly shape processes, quality systems, and long-term success.

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