QA & Regulatory Affairs Specialist: Drive Quality & Compliance

EMED Technologies Corporation; New York (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

EMED Technologies Corporation is seeking a Quality Assurance and Regulatory Affairs Specialist to support the company’s QMS and ensure compliance with applicable regulations. You will work closely with CA/QA/RA leadership and cross-functional teams to maintain documentation, CAPA, and audit readiness.

The role emphasizes document control, CAPA investigations, handling nonconforming product, customer complaints, and quality metrics reporting, with opportunities to engage in internal and supplier

Qualifications

• Bachelor's degree in Science, Engineering or related field.
• Minimum of 3 years of experience in Quality Assurance in pharmaceutical and/or medical device industries.
• Knowledge of MS Office Suite (Excel, Word, Outlook).
• Excellent interpersonal skills, ability to meet deadlines, manage priorities and work well under pressure.

Responsibilities

• Administration of Document Control function, including document ID issuance, revision control, coordination of review and approval, communication of implementation tasks, and maintenance of all records.
• Lead/assist with CAPA investigations, plan development and implementation of corrective actions, author CAPA reports, and ensure completion and accuracy of all associated Quality records.
• Support nonconforming product handling and disposition assessments and manage all records.
• Coordinate the efficient handling and resolution of Customer Complaints, working with contract manufacturer sites and other EMED departments, and manage all records.
• Perform reporting and trending on Quality metrics to ensure an oversight of the compliance landscape for the site.
• Support external audits/inspections with audit readiness preparations, back-room support and response writing to non-conformances.
• May serve as an Internal/Supplier Auditor and conduct audits per schedule
• Write new and revise existing QMS standard operating procedures as directed.
• Review, approve, and maintain device history record files.
• Identify, initiate, and lead process and compliance improvement as requested.
• Interface with other EMED departments such as Engineering, Operations, Customer Service, and Regulatory Affairs as necessary to ensure success for assigned responsibilities.
• Support various Quality Assurance activities as assigned under minimal supervision/instruction.
• Assist with Regulatory Affairs tasks as assigned
• Ensure that all Quality Assurance related tasks and responsibilities defined in EMED Quality Management System Documentation are performed, as defined.

Skills

Interpersonal skills

Time management

Self-directed work

Education

Bachelor's degree in Science, Engineering or related field

Tools

MS Office Suite

Job description

EMED Technologies Corporation is seeking a Quality Assurance and Regulatory Affairs Specialist to support the company’s QMS and ensure compliance with applicable regulations. You will work closely with CA/QA/RA leadership and cross-functional teams to maintain documentation, CAPA, and audit readiness.

The role emphasizes document control, CAPA investigations, handling nonconforming product, customer complaints, and quality metrics reporting, with opportunities to engage in internal and supplier