Intellectt Inc
Job Title
Design Quality Engineer
Location New Jersey
Duration Long‑Term Contract
Role Overview The Design Quality Engineer will lead and execute quality engineering activities focused on DHF remediation. The role involves reviewing and updating legacy design documentation, collaborating across functions, and ensuring that all design controls, risk management, and related documentation meet regulatory standards.
Key Responsibilities
Lead DHF remediation activities, ensuring compliance with 21 CFR Part 820, ISO 13485, and other applicable regulatory standards.
Review and update legacy DHF documents, including design inputs/outputs, verification & validation (V&V), risk management files, and traceability matrices.
Collaborate with R&D, Regulatory Affairs, and Quality Systems to identify gaps and implement corrective actions for compliance.
Support design control deliverables throughout the product lifecycle, ensuring proper documentation and risk mitigation.
Conduct design reviews, change control assessments, and document updates as part of remediation activities.
Provide technical guidance and quality oversight during remediation and any required re‑verification or testing activities.
Ensure design control documentation aligns with current quality system procedures and standards.
Required Skills & Experience
Minimum 5 years of experience in Design Quality Engineering within the medical device industry.
Strong expertise in risk management and regulatory compliance.
Familiarity with FDA regulations and international standards relevant to medical devices.
Knowledge of IEC 60601 and IEC 62304 standards.
Seniority level Mid‑Senior level
Employment type Contract
Job function Quality Assurance
Industries Medical Equipment Manufacturing
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Location New Jersey
Duration Long‑Term Contract
Role Overview The Design Quality Engineer will lead and execute quality engineering activities focused on DHF remediation. The role involves reviewing and updating legacy design documentation, collaborating across functions, and ensuring that all design controls, risk management, and related documentation meet regulatory standards.
Key Responsibilities
Lead DHF remediation activities, ensuring compliance with 21 CFR Part 820, ISO 13485, and other applicable regulatory standards.
Review and update legacy DHF documents, including design inputs/outputs, verification & validation (V&V), risk management files, and traceability matrices.
Collaborate with R&D, Regulatory Affairs, and Quality Systems to identify gaps and implement corrective actions for compliance.
Support design control deliverables throughout the product lifecycle, ensuring proper documentation and risk mitigation.
Conduct design reviews, change control assessments, and document updates as part of remediation activities.
Provide technical guidance and quality oversight during remediation and any required re‑verification or testing activities.
Ensure design control documentation aligns with current quality system procedures and standards.
Required Skills & Experience
Minimum 5 years of experience in Design Quality Engineering within the medical device industry.
Strong expertise in risk management and regulatory compliance.
Familiarity with FDA regulations and international standards relevant to medical devices.
Knowledge of IEC 60601 and IEC 62304 standards.
Seniority level Mid‑Senior level
Employment type Contract
Job function Quality Assurance
Industries Medical Equipment Manufacturing
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