Quality Engineer II

📍 Columbia, MD

Are you a quality-driven professional with experience in medical devices, regulated manufacturing, or quality systems? We are seeking a Quality Engineer II to support our Columbia, MD site by maintaining critical quality management systems, driving continuous improvement initiatives, and ensuring compliance with global regulatory requirements.

In this role, you will partner cross-functionally with Manufacturing, R&D, Operations, and Quality teams to support product development, commercial manufacturing, validation activities, investigations, and quality system improvements.

Key Responsibilities

• Lead and maintain change management activities, including quality impact assessments and implementation planning.
• Investigate quality events, determine root causes, and drive effective corrective and preventive actions (CAPAs).
• Author, review, and approve quality documentation, including SOPs, validation protocols and reports, specifications, investigations, and quality plans.
• Support validation activities for products, processes, equipment, and systems.
• Monitor and maintain critical quality control programs, including calibration, preventive maintenance, environmental monitoring, and change control.
• Support new product introductions and technology transfers from development through commercialization.
• Analyze quality and manufacturing data, identify trends, and provide statistical analysis to support decision-making.
• Prepare monthly and quarterly quality metrics, trending reports, and Statistical Process Control (SPC) documentation.
• Participate in FDA inspections, ISO certification audits, surveillance audits, and customer audits.
• Collaborate with cross-functional teams to improve processes, resolve quality issues, and ensure compliance with regulatory and quality requirements.

Required Qualifications

• Bachelor's degree in Engineering, Science, Quality, or a related technical discipline. Advanced degree preferred.
• Experience working within regulated industries such as medical devices, biotechnology, pharmaceuticals, or healthcare manufacturing.
• Knowledge of quality systems and applicable regulations, including:
  • FDA QMSR / 21 CFR Part 820
  • 21 CFR Part 11
  • ISO 13485
  • EU MDR (2017/745)
  • Canadian Medical Device Regulations (CMDR)
• Experience with change management, quality investigations, CAPA, validation, or quality systems.
• Understanding of statistical methods, sampling plans, and data analysis.
• Strong technical writing skills and experience creating quality system documentation.
• Excellent project management, communication, and organizational skills.
• Ability to work independently while managing multiple priorities in a fast-paced environment.

Preferred Qualifications

• ASQ, RAPS, or similar quality/regulatory certification.
• Experience with electronic Quality Management Systems (eQMS) and ERP systems.
• Knowledge of data integrity principles and computerized system validation.
• Experience with data trending, reporting, automation, coding, or scripting.
• Prior participation in regulatory inspections and external audits.

Why Join Us?

• Work on innovative medical device products that impact patient lives.
• Collaborate with talented cross-functional teams.
• Gain exposure to product development, manufacturing, validation, and regulatory activities.
• Opportunities for professional growth and advancement within Quality Engineering.