Job Description In compliance with FDA, European MDD/MDR & ISO regulations, the Senior Quality Systems Specialist- QMS will perform work under general supervision. This role assists in maintaining quality compliance, managing new geographies Quality Compliance Assessments, managing actions for audit findings and CAPAs, supporting the External Standards management process, supporting audit activities, and compiling quality metrics. The position requires frequent use and general knowledge of industry practices, techniques, and standards. Responsibilities + Ensure Quality Management System procedures are established and maintained in compliance with International, National, and Local regulatory requirements and company policies. + Identify changes to relevant regulatory requirements and industry standards. + Undertake gap assessment activities to newer regulatory requirements. + Work cross-functionally to address identified system gaps and implement changes. + Train the organization to ensure new requirements are communicated and understood. + Implement Standards and Regulation tracking and information collection tools, maintain Standards logs with current revisions, and report on progress of implementation. + Provide QA support for International Product Registration. + Ensure regulatory compliance with US, Europe, and other international regulations to ensure market access and support commercialization efforts. + Compile Quality records to support international regulatory submissions. + Assist with Internal and External Audit Activities. Essential Skills + Bachelor’s degree and 5+ years of related experience performing Quality System related activities in the medical device industry. + Working knowledge of cGMP, FDA 820 QSR, and ISO or other Quality Systems. + Proficiency in data compilation, analysis, presentation, and document writing skills. + Excellent written and verbal communication skills. + Excellent organizational skills. + Experience with computer-based applications (MS Word, MS Excel, QAD). + Strong time management skills and the ability to multi-task in a fast-paced environment. + Ability to operate as a team player and/or independently while demonstrating flexibility to changing requirements. Additional Skills & Qualifications + Audit + Medical Device + Quality Systems Management + NCR + Quality Assurance + Regulatory Compliance Work Environment Collaborative working environment with an immediate team of 4 members and an additional 2 - 3 cross-functional team members. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.