Job Title: Quality Engineer Must have Medical Device Job Description The overall goal of the Validation Engineer is to ensure that all manufacturing processes (internal and outsourced) used by the company to manufacture medical devices are validated to ensure product quality and compliance with federal regulations and industry standards, including but not limited to, 21 CFR 820 and ISO standards. The Validation Engineer will work independently with objectives provided by the Project Manager and will be the sole Validation Engineer in the US. Key responsibilities include developing and maintaining facilities, processes, and equipment validations, coordinating with various departments and subcontractors, maintaining the validation master plan, and ensuring compliance with regulatory requirements. Hard Skills + Validation of manufacturing processes + Compliance with 21 CFR 820 and ISO standards + Risk management principles + Data analysis + Development of validation packages + Creation of protocols from scratch + Validation of machinery, machine parts, coating, instruments, laser etching, packaging, labeling, molding, sterilization (ETO or Gamma), and implants Soft Skills + Independent work + Coordination with departments and subcontractors + Process improvement identification + Project management + Effective communication Job Type This is a contract-to-hire position with a duration of 9 Month(s). Work Site This is a fully on-site position in Dallas, Texas. Work Environment The position involves working on the manufacturing floor with equipment such as machinery, machine parts, coating, instruments, laser etching, packaging, labeling, molding, sterilization (ETO or Gamma), and implants. The role requires maintaining a schedule and driving to meet validation goals aligned with project objectives. 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.