Contract Design Quality Engineer - DHF/QMS Migration

Redline Group; New York (NY, MA); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Redline Group client in the US is seeking an experienced Contract - Design Quality Engineer to support a DHF and QMS migration in a regulated Medical Device environment.

The role is based in New York or Massachusetts with hybrid work (approx. 2 days per month) and a 12-month duration. The successful candidate will collaborate with Quality, Regulatory Affairs, R&D and Manufacturing to ensure design control compliance and documentation integrity.

Qualifications

• Bachelor's degree in Biomedical or Mechanical Engineering.
• Experience in Design Quality Engineering in Medical Device.
• Knowledge of DHF, DMR, DHR and Design Control.
• Experience with ISO 13485, FDA 21 CFR 820 and EU MDR.
• Experience with Risk Management (ISO 14971), V&V and Change Management.

Responsibilities

• Execute DHF and QMS migration activities.
• Review, update and remediate design documentation for regulatory compliance.
• Assess and approve Design Control documentation with traceability.
• Support DHF remediation, data integrity, document consolidation.
• Collaborate with Quality, Regulatory Affairs, R&D and Manufacturing to enable design transfers.
• Identify and resolve gaps against ISO 13485, FDA 21 CFR 820 and EU MDR requirements.
• Support audit prep, inspection readiness and quality system compliance initiatives.
• Participate in change control activities and assess quality/regulatory impacts.
• Ensure documentation aligns with internal quality systems and design controls.

Skills

Design Quality Engineering

Regulatory compliance

Documentation & cross-functional

ISO 13485 knowledge

FDA 21 CFR 820 knowledge

EU MDR knowledge

Risk Management (ISO 14971)

V&V (Verification & Validation)

Change Management

Education

Bachelor's Degree in Biomedical Engineering, Mechanical Engineering or related discipline

Job description

Redline Group client in the US is seeking an experienced Contract - Design Quality Engineer to support a DHF and QMS migration in a regulated Medical Device environment.

The role is based in New York or Massachusetts with hybrid work (approx. 2 days per month) and a 12-month duration. The successful candidate will collaborate with Quality, Regulatory Affairs, R&D and Manufacturing to ensure design control compliance and documentation integrity.