Senior Quality Engineer – Medical Devices & Compliance

Actalent; Edison (NJ); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

401k with company match

Paid vacation and sick time

Job summary

Actalent is seeking a Quality Engineer for our Edison, NJ site to lead and improve the Quality Management System for Class II medical devices. The role ensures compliance with ISO 9001:2015 and FDA requirements while guiding cross-functional teams through quality initiatives.

The successful candidate will drive supplier quality, support new product development, and prepare for audits. This is a fully onsite permanent role at Edison, NJ with a strong emphasis on continuous improvement and

Qualifications

• Bachelor's degree in engineering required.
• 5+ years of quality engineering experience in medical devices.
• Familiar with ISO-based QMS incl. ISO 9001:2015.
• Experience with FDA requirements for Class II devices.
• Experience preparing for and supporting external audits.

Responsibilities

• Implement and maintain a quality program aligned with ISO 13485 and FDA requirements.
• Maintain and improve the Quality Management System per ISO 9001:2015 and FDA standards.
• Develop and maintain Quality Manual, policies, procedures, and forms.
• Coordinate external audits and interact with certifying bodies and FDA.
• Lead internal audit programs and drive improvements in QMS.

Skills

Bachelor degree in engineering

5+ years quality engineering

ISO 9001:2015 awareness

FDA regulatory knowledge

Internal audit experience

Cross-functional collaboration

Quality system management

Supplier quality management

Quality improvement leadership

Education

Bachelor’s degree in engineering

Job description

Actalent is seeking a Quality Engineer for our Edison, NJ site to lead and improve the Quality Management System for Class II medical devices. The role ensures compliance with ISO 9001:2015 and FDA requirements while guiding cross-functional teams through quality initiatives.

The successful candidate will drive supplier quality, support new product development, and prepare for audits. This is a fully onsite permanent role at Edison, NJ with a strong emphasis on continuous improvement and