Melville, NY, 11747, USA
18 days ago
Quality Assurance Associate - Regulatory Affairs
**Req Number** 162058 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. + Location: Hybrid, both remote and onsite in Melville, NY + Schedule: M-F 9:00am to 5:30pm + Temporary: long term assignment: July 2025-June 2026 + Pay Rate: $27/hr This position is responsible to support the Quality Assurance and Trade Compliance teams in meeting 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.) Responsibilities: + Data entry in various quality and regulatory management systems + Assist in trade compliance daily tasks + Participate in special projects and perform other duties as required Other skills: + Knowledge of US import, export regulations, US customs, FDA and ISO. + 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 US Customs/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). The salary range for this position is $27-$27/hour It is Northwell Health’s policy to provide equal employment opportunity and treat all applicants and employees equally regardless of age, race, creed/religion, color, national origin, immigration status, or citizenship status, military or veteran status, sexual orientation, sex/gender, gender identity, gender expression, height, weight, disability, pregnancy, genetic information or genetic predisposition or carrier status, marital or familial status, partnership status, victim of domestic violence, their or their dependent’s sexual or other reproductive health decisions, or other characteristics protected by applicable law.
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