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

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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.

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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

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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

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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.