Overview:
The RA/QA Associate will work under the direct supervision of the Director – RA/QA. The RA/QA Associate will be responsible for (but not limited to) the following tasks:

o Support the operation and continuous improvement of the Quality Management System.

o Revision and creation of operating procedures, specifications, test methods, and inspection forms.

o Support internal and external audit program, develop corrective and preventive action plans, and verify the effectiveness of activities.

o Conduct presentations to Top Management regarding product and process quality.

o Review products, processes, and documents for compliance with applicable regulatory requirements and conformance to recognized standards and customer specifications.

o Communicate with customers regarding product quality, addressing their regulatory requests, complaint investigations, supplier qualifications, etc.

o Perform data and trending analysis of product and process performance.

EDUCATION: B.A./B.S. required (background in Science preferred but not required)

EXPERIENCE: 1 years working in Quality Assurance preferred

REQUIRED SKILLS: Proficient in Microsoft Office. Ability to communicate and present information clearly both verbally and in writing. Project management skills. Ability to analyze and trend data sets. Ability to work independently as well as in a team environment. Understanding of ISO 13485:2016 and FDA 21 CFR 820 a plus.

COMPENSATION: $45,000 - $50,000 per year

BENEFITS: Health, Dental and Vision Plans, 401k Plan, Pre-Tax Commuter Benefits Plan, and Gym Reimbursement.

Job Type: Full-time

Pay: $45,000.00 - $50,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Experience level:

• 1 year

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

People with a criminal record are encouraged to apply

Education:

• Bachelor's (Required)

Experience:

• FDA regulations: 1 year (Required)

Ability to Commute:

• Long Island City, NY (Required)

Ability to Relocate:

• Long Island City, NY: Relocate before starting work (Preferred)

Work Location: In person