Contract - Design Quality Engineer

Redline Group Ltd; New York (NY); Hybrid; USD 83,000 - 124,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Documentation

Stakeholder management

Communication skills

Education

Bachelor's Degree in Biomedical Engineering or Mechanical Engineering

Job description

Our New York & Massachusetts based client is an established engineering consultancy supporting Medical Device, Life Sciences, Pharmaceutical and Biopharmaceutical organizations across the United States.Their teams provide specialist expertise across Quality Engineering, Manufacturing Engineering, Supply Chain, Project Management, Validation and Regulatory Affairs, supporting both site-based and enterprise-wide programs.

Typical project activity includes new product introduction (NPI), product development, quality remediation, CAPA, manufacturing improvement, operational readiness, process validation, regulatory compliance and business transformation initiatives.

As a result of increased project demand, they are seeking experienced contractors to support a range of ongoing and newly awarded programs.

Contract - Design Quality Engineer

Location: New York / Massachusetts

Duration: 12 months (W2 or C2C considered)

Hybrid - approximately 2 days per month (dependent on project need; this may increase when required)

Applicants must be authorized to work in the United States.Visa sponsorship is not available for this position

About the Role

We are seeking an experienced Contract - Design Quality Engineer to support a critical Design History File (DHF) and Quality Management System (QMS) migration program within a regulated Medical Device environment.

This position will play a key role in ensuring product design documentation, quality records and regulatory compliance activities are successfully transferred, remediated and aligned to current quality and regulatory standards.The successful candidate will work cross-functionally with Quality, Regulatory Affairs, R&D and Manufacturing teams to support documentation integrity, design control compliance and inspection readiness.

Key Responsibilities of the Contract - Design Quality Engineer role, based in New York or Massachusetts

• 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.

Required Experience of the Contract - Design Quality Engineer

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

We look forward to hearing from you.