Quality Assurance Associate - Regulatory Compliance-Long Term Temp

FlexStaff is seeking a Quality Assurance Associate for a long term temporary role with our client, a leading distributor of health care supplies and equipment.

Job Location: Melville, New York
M-F 9:00am to 5:30pm
Temporary: April 2025-March 2026
Pay Rate: $27/hr

RESPONSIBILITIES:

This position is responsible to support the compliance of the Quality Management System with Regulatory requirements and internal processes. To ensure quality of products, components and/or operations using standard procedures (e.g. ISO 13485:13485, MDSAP, 21 CFR part 211, 820, 803, 806 etc.)

• Verify UDI barcodes to ensure that the barcodes comply with FDA requirements
• Review and approve packaging/labels for all private label products to assure compliance with applicable regulatory requirements
• Represent Quality Assurance to support other departments with Quality and Regulatory issues/questions
• Participate in special projects and perform other duties as required

Other skills:

• Knowledge of FDA.
• Able to work independently.
• Effective verbal and written communication skills, excellent customer service background, data entry experienced.
• Able to follow written SOPs and formal procedural documents.
• Able to multi-task and handle multiple projects under pressure.
• Able to quickly process large volumes of administrative forms in an efficient manner with a high degree of accuracy and quality.
• Able to be flexible and change directions as necessary.
• Performs clerical functions, including but not limited to copying, filing, scanning, faxing, etc.
• Ability to follow instructions, superb attention to detail and, verbatim compliance to procedure.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Perform moderate trouble shooting with minimal supervision.
• Ability to embrace change and participate in continuous improvement activity.

Preferred Education:

• Prefer 4-year college degree in science related field with 0-1 year Quality/Regulatory experience in the pharmaceutical or medical device industry.

*Additional Salary Detail

The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).