Description: • Develop, implement, and maintain the Company's Quality Management System. • Represent Company's Quality Management system during third party registration surveys. • Maintain the internal quality audit program and to report on the performance of the system to the Management Review as an ongoing basis for improvement. • Provide technical support to company operations, and manage the Quality Department activities, including employee training and performance. • External customer liaison providing required documentation for new product development, supplier quality problems/resolutions and corrective actions. • Maintain general quality department compliance to developed procedures and requirements. • Participate in MRB and approve all internal Inspection Rejection reports for corrective action effectiveness at completion and distribute results to management team. • Acts as the local ISO Management Representative per CLIENT Quality Management System (QMS) Supervisory Responsibility: • Plan, organize, analyze, and implement all quality improvements and initiatives. • Communicate and Implement appropriate Corrective Actions for any negative observations or areas of improvements during third party registration audits. • Provide and implement effective corrective actions to resolve customer / supplier issues. • Issue required and approved appropriate corrective action to suppliers. • Staff, procure, and maintain required Quality Assurance department resources. Additional Skills & Qualifications: Job Description Experience, Knowledge, Skills and Abilities required: • Education: Bachelor's degree in a related field (Engineering, Quality, Business Management). • Experience: 5+ years of experience in an ISO/FDA quality system environment. • Formal quality certifications. • Extensive experience with Good Manufacturing Practices (GMP), ISO standards (i.e. ISO 13485) or 21 CFR 820 within a regulated industry. • Advanced Microsoft Word and Excel, PowerPoint, Visio, Statistical Process Control (SPC) using statistics, as well as document revision control software for policies and procedures management. • Combinations of education, training, and experience to successfully accomplish responsibilities. • Extensive knowledge of compliance and processes. 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.