QA & Regulatory Affairs Specialist – Medical Devices

EMED Technologies; New York (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

A medical device leader in New York seeks a Quality Assurance and Regulatory Affairs Specialist to support compliance with regulations and manage Quality Management System tasks. The ideal candidate holds a Bachelor’s degree in Science or Engineering and has at least 3 years of experience in Quality Assurance in the pharmaceutical or medical device industry. Key responsibilities include document control, handling customer complaints, and reporting on quality metrics. Strong interpersonal and problem-solving skills are essential for success in this role.

Qualifications

• Minimum of 3 years of experience in Quality Assurance in pharmaceutical and/or medical device industries.

Responsibilities

• Support EMED’s Quality Management System and ensure compliance with regulations.
• Lead/assist with Corrective and Preventative Action (CAPA) investigations.
• Coordinate Customer Complaints resolution and manage records.
• Write and revise QMS standard operating procedures.

Skills

Knowledge of MS Office Suite (Excel, Word, Outlook)

Excellent interpersonal skills

Ability to manage priorities

Self-directed and deal with ambiguous issues

Education

Bachelor’s degree in Science, Engineering or related field

Job description

A medical device leader in New York seeks a Quality Assurance and Regulatory Affairs Specialist to support compliance with regulations and manage Quality Management System tasks. The ideal candidate holds a Bachelor’s degree in Science or Engineering and has at least 3 years of experience in Quality Assurance in the pharmaceutical or medical device industry. Key responsibilities include document control, handling customer complaints, and reporting on quality metrics. Strong interpersonal and problem-solving skills are essential for success in this role.