In-Person Position

The Manufacturing Quality Engineer is responsible for ensuring that manufacturing processes meet applicable regulatory and internal quality requirements. This role will be pivotal in scaling production of our cleared x-ray device, the MC2 Portable X-Ray System, managing process validations, supporting nonconformance resolution, and driving continuous improvement on the manufacturing line and within the quality management system.

Key Responsibilities:

• Ensure compliance with FDA 21 CFR 820 and ISO 13485 during manufacturing and inspection processes.
• Lead and support process validation activities (IQ/OQ/PQ), test method validations (TMV), and equipment qualifications.
• Review and approve Device History Records (DHRs) for completeness and compliance prior to product release; identify and resolve discrepancies.
• Maintain DHR templates to ensure accurate documentation of manufacturing activities.
• Manage manufacturing nonconformance records and CAPAs; lead root cause investigations and implement effective corrective/preventive actions.
• Develop and maintain manufacturing quality documentation including inspection procedures and work instructions.
• Conduct line audits and floor inspections to verify adherence to Good Manufacturing Practices (GMPs) and internal quality standards.
• Participate in internal and external audits and support timely responses to observations/findings.
• Maintain and update PFMEAs and participate in risk assessments related to process changes and product quality.
• Collaborate with cross-functional teams including Engineering, Operations, and Regulatory Affairs during NPI and design transfer.
• Monitor process performance through data analysis and statistical tools to support continuous improvement initiatives.
• Responsible for incoming inspections.
• Support supplier quality activities and product release processes.

Required Qualifications:

• Bachelor’s degree in Engineering (Industrial, Biomedical, or related field).
• Minimum 2 years of quality engineering experience in a regulated medical device manufacturing environment.
• Proficient in ISO 13485, 21 CFR 820, and design control requirements.
• Hands-on experience with process validation (IQ/OQ/PQ), CAPA, FMEA, and DHR review.
• Familiarity with risk management per ISO 14971.
• Strong analytical, documentation, and problem-solving skills.

Preferred Qualifications:

• Experience with radiological or electromechanical medical devices.
• Familiar with engineering drawings and GD&T.

Work Environment:

This role is based in a hands-on production environment and will interface closely with manufacturing personnel. Our manufacturing facility is located in Midtown.