Senior QA Manager, Medical Devices & Pharma

Guerbet; Princeton (NJ); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Continued personal development

Diversity and inclusion initiatives

Job summary

A global leader in medical imaging is seeking a qualified QA Manager in Princeton, NJ. This role involves enhancing the quality management system, ensuring compliance with FDA regulations, and overseeing audit processes. The ideal candidate will have a minimum of 8 years of QA experience in the pharmaceutical industry, an advanced degree in a relevant field, and strong communication and project management skills. Join a multicultural team dedicated to improving patient quality of life through innovative solutions.

Qualifications

• Minimum of 8 years of QA experience in the pharmaceutical/medical device industry.
• Demonstrated expertise in FDA regulations and ISO standards.
• Proven experience in audit management and non-conformity resolution.

Responsibilities

• Ensure compliance with FDA regulations and applicable legislative requirements.
• Oversee the Customer Complaints system and facilitate investigations.
• Coordinate, evaluate, and follow up on CAPAs related to audit findings.

Skills

Excellent communication skills

Project management

Analytical skills

Attention to detail

Problem-solving skills

Education

Advanced degree in Chemistry, Engineering, or Life Sciences

Tools

Electronic quality management systems

Job description

A global leader in medical imaging is seeking a qualified QA Manager in Princeton, NJ. This role involves enhancing the quality management system, ensuring compliance with FDA regulations, and overseeing audit processes. The ideal candidate will have a minimum of 8 years of QA experience in the pharmaceutical industry, an advanced degree in a relevant field, and strong communication and project management skills. Join a multicultural team dedicated to improving patient quality of life through innovative solutions.