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 SkillsValidation of manufacturing processesCompliance with 21 CFR 820 and ISO standardsRisk management principlesData analysisDevelopment of validation packagesCreation of protocols from scratchValidation of machinery, machine parts, coating, instruments, laser etching, packaging, labeling, molding, sterilization (ETO or Gamma), and implantsSoft SkillsIndependent workCoordination with departments and subcontractorsProcess improvement identificationProject managementEffective communicationJob 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 for other accommodation options.