Global Director, Design Assurance & Quality

Nova Biomedical Corporation; Waltham (MA); Hybrid; USD 175,000 - 240,000; Full time

Benefits offered by this job

Hybrid work arrangements

Competitive 401k

Bonus program

Generous PTO and paid holidays

Cafeteria in MA offices

Job summary

Nova Biomedical seeks a Director, Design Assurance to lead global design assurance and design control across medical devices and non-medical bioprocessing portfolio, ensuring compliance with FDA QMSR, ISO 13485, 14971, 9001; partner with R&D, Regulatory, Manufacturing, and others to support product development and lifecycle management.

The role emphasizes risk management integration, design reviews, verification/validation, software lifecycle quality, cybersecurity, and readiness for audits;

Qualifications

• Bachelor's degree in Engineering or related field required.
• Minimum 15 years of experience in medical device/regulated industries.
• Minimum 10 years of progressive leadership in quality/design assurance.
• Experience supporting FDA inspections and international regulatory assessments.
• Knowledge of FDA QMSR, ISO 13485, ISO 14971, ISO 9001, IVDR, MDSAP.

Responsibilities

• Lead global Design Assurance for new product development, changes, systems, and lifecycle management.
• Establish and maintain design control processes: planning, inputs/outputs, reviews, verification, validation, transfer, changes.
• Integrate risk management across lifecycle per ISO 14971 and related standards.
• Provide leadership for software lifecycle quality, including cybersecurity considerations.
• Support regulatory inspections, audits, and governance activities.

Skills

Design Assurance leadership

Regulatory compliance

Risk management

Cross-functional leadership

Quality systems knowledge

Education

Bachelor's degree in Engineering or related

Master's degree preferred

Tools

Electronic document management systems

Quality management software

Job description

Nova Biomedical seeks a Director, Design Assurance to lead global design assurance and design control across medical devices and non-medical bioprocessing portfolio, ensuring compliance with FDA QMSR, ISO 13485, 14971, 9001; partner with R&D, Regulatory, Manufacturing, and others to support product development and lifecycle management.

The role emphasizes risk management integration, design reviews, verification/validation, software lifecycle quality, cybersecurity, and readiness for audits;