Hybrid Design Quality Engineer for Medical Devices (DHF/QMS)

Redline Group Ltd; New York (NY); Ibrido; USD 83.000 - 124.000; Tempo pieno

Descrizione del lavoro

Redline Group Ltd's client in New York/Massachusetts is seeking an experienced Contract - Design Quality Engineer to support DHF and QMS migrations within a regulated medical device environment. You will ensure documentation integrity, regulatory alignment, and cross-functional collaboration with Quality, Regulatory Affairs, R&D and Manufacturing.

The role emphasizes design transfer, remediation, and compliance with ISO 13485, FDA 21 CFR 820 and EU MDR, with responsibility for inspection

Competenze

• Bachelor's degree in Biomedical Engineering or Mechanical Engineering.
• Proven experience within Design Quality Engineering in a Medical Device or regulated Life Sciences environment.
• Strong understanding of DHF, DMR, DHR and Design Control processes.
• Experience supporting QMS migration, DHF remediation, design transfer or document harmonization projects.
• Working knowledge of ISO 13485, FDA 21 CFR 820 and EU MDR regulations.
• Experience with Risk Management (ISO 14971), Verification & Validation (V&V) and Change Management activities.
• Strong documentation, stakeholder management and communication skills.

Mansioni

• Execute Design History File (DHF) and Quality Management System (QMS) migration activities.
• Review, update and remediate design documentation to ensure compliance with regulatory requirements.
• Assess and approve Design Control documentation, ensuring complete traceability throughout the product lifecycle.
• Support DHF remediation, document consolidation and data integrity activities.
• Collaborate with Quality, Regulatory Affairs, R&D and Manufacturing teams to facilitate successful design transfer activities.
• Identify and resolve gaps against ISO 13485, FDA 21 CFR 820 and EU MDR requirements.
• Support audit preparation, inspection readiness and quality system compliance initiatives.
• Participate in change control activities and assess quality and regulatory impacts.
• Ensure all documentation aligns with internal quality systems, design control requirements and regulatory expectations.

Conoscenze

Documentation

Stakeholder management

Communication skills

Formazione

Bachelor's Degree in Biomedical Engineering or Mechanical Engineering

Descrizione del lavoro

Redline Group Ltd's client in New York/Massachusetts is seeking an experienced Contract - Design Quality Engineer to support DHF and QMS migrations within a regulated medical device environment. You will ensure documentation integrity, regulatory alignment, and cross-functional collaboration with Quality, Regulatory Affairs, R&D and Manufacturing.

The role emphasizes design transfer, remediation, and compliance with ISO 13485, FDA 21 CFR 820 and EU MDR, with responsibility for inspection