Mahwah, NJ, 07430, USA
1 day ago
Specialist, Quality Assurance - Individual Contributor
Description We are looking for a dedicated Regulatory Affairs Quality Assurance Specialist to join our team in Mahwah, New Jersey. In this role, you will play a crucial part in managing document-related changes while ensuring compliance with regulatory standards for medical devices. This is a long-term contract position that offers the opportunity to contribute to the continuous improvement of quality processes and documentation practices. Responsibilities: • Oversee and facilitate the change management process for document-related updates in alignment with organizational procedures. • Administer and maintain the learning management system to ensure seamless training and documentation processes. • Ensure all documentation accurately reflects business activities while adhering to internal and external regulatory requirements. • Promote and uphold Good Documentation Practices across organizational processes. • Identify and implement process improvements to enhance the efficiency and effectiveness of documentation systems. • Support compliance with medical device regulations and quality assurance standards. • Collaborate with cross-functional teams to ensure consistent adherence to regulatory and corporate requirements. • Provide guidance on documentation strategies to ensure alignment with industry best practices. Requirements • Strong communication and interpersonal skills to effectively collaborate with diverse teams. • Proficiency in Microsoft Office tools, including Word, Excel, and Power BI. • Familiarity with electronic document management and learning management systems. • Solid understanding of quality assurance principles and regulatory requirements for medical devices. • Experience in change management and process improvement methodologies. • Ability to analyze compliance risks and implement corrective measures. • Knowledge of Good Documentation Practices and relevant industry standards. • Bachelor’s degree in a related field such as engineering, quality assurance, or a similar discipline. TalentMatch® Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles. Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app (https://www.roberthalf.com/us/en/mobile-app) and get 1-tap apply, notifications of AI-matched jobs, and much more. All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information. © 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to Robert Half’s Terms of Use (https://www.roberthalf.com/us/en/terms) .
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