Job Title: Quality Management Systems SpecialistJob Description We are seeking a Quality Management Systems Specialist who will be responsible for ensuring compliance with internal and external regulatory requirements, including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements. This role involves engaging in the development of an optimum future state of QMS tailored to business needs, executing development and modification processes, and contributing to quality planning and management review forums. Responsibilities + Ensure QMS compliance with internal and external regulatory requirements. + Engage in the development of the future state of QMS for business needs. + Contribute improvements and inputs into the quality planning process. + Execute development and modification of the Quality Management System. + Facilitate Management Review and Quality Planning Review. + Assess and quantify requirements for optimizing QMS structure. + Promote GMP and GDP within the Quality organization. + Identify and implement improvement opportunities to enhance QMS efficiency and effectiveness. + Support the development, maintenance, and improvement of policies and procedures. + Implement best-in-class practices and benchmark against industry leaders and regulatory requirements. + Manage communication with notified bodies. + Ensure QMS supports actual activities and business needs, including NPD requirements. + Participate in relevant QMS IS discussions. + Contribute to QMS business processes and understand IS system support requirements. + Conduct internal and external quality system audits. + Understand system integration and IS change control assessment and approval. Essential Skills + Document control. + Experience with Medical Device Regulations. + Proficiency in Quality Systems and QMS. + Understanding of ECO's and ECR's. + Experience with medical device product development lifecycle, including risk management and design/process verification and validation. + Knowledge of Advanced Quality tools such as FMEA, GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke. + Ability to read and interpret CAD drawings. + Experience in interacting with regulatory agencies such as FDA, MoH, and TUV. + Thorough knowledge of US and International Medical Device Regulations. + Strong knowledge of Quality Concepts, including CAPA, Audits, and Statistics. + Strong project management skills. Additional Skills & Qualifications + Ability to manage multiple tasks simultaneously. + Proven advocacy for product excellence and quality. + Experience in working cross-functionally with departments such as Advanced Operations, Product Development, Regulatory Affairs, and Marketing. + Strong interpersonal, written, oral communication, and negotiation skills. + Critical thinking and 'outside the box' thinking. + Highly developed problem-solving and analytical skills. + Experience in managing and completing projects in a matrix organization. + Ability to work independently. + Experience in compliance risk situations. + Computer literacy, including proficiency with Mini-Tab or similar analysis programs. Work Environment The work environment is dynamic and encourages professional growth. Employees are provided with 2 weeks of PTO and 10 paid holidays. The role involves collaboration with various departments, utilizing advanced technologies and methodologies to maintain regulatory compliance and product quality. Dress code adheres to professional standards. Pay and Benefits The pay range for this position is $32.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Irvine,CA. Application Deadline This position is anticipated to close on Jun 30, 2025. 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. 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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.