Senior Process Quality Engineer, Med Devices & Scale-Up

Elutia; Gaithersburg (MD); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Equity

Performance-based bonus

Medical, dental, vision, life

401(k) with employer match

Paid time off

Job summary

Elutia seeks a hands-on Process Quality Engineer to drive quality activities for transfer, scale-up, and commercial manufacture of drug-eluting products. You will partner with Operations and R&D to translate development into robust, controlled processes, support process characterization, studies, and risk-based decisions.

You’ll also contribute to CAPA, change control, and audits on the Quality Management System.

Qualifications

• Minimum Bachelor's in engineering, science, or related field.
• 5+ years of Quality/Process/Mfg Engineering in regulated environments.
• Experience with change control, investigations, CAPA, and risk management.
• Knowledge of FDA QMSR and ISO 13485.
• Strong problem-solving abilities and independent drive.

Responsibilities

• Support development, scale-up, transfer, and manufacturing process implementation.
• Contribute to process optimization, characterization, and validation studies.
• Identify critical process parameters and controls.
• Lead change controls and nonconformance investigations.
• Support Quality Management System processes and audits.

Education

Bachelor's degree in engineering, science, or a related technical discipline

Job description

Elutia seeks a hands-on Process Quality Engineer to drive quality activities for transfer, scale-up, and commercial manufacture of drug-eluting products. You will partner with Operations and R&D to translate development into robust, controlled processes, support process characterization, studies, and risk-based decisions.

You’ll also contribute to CAPA, change control, and audits on the Quality Management System.