Quality Engineer at Actalent — NeverHard

The Senior Design Quality Engineer provides dedicated quality engineering support for development activities performed on behalf of customers, including new product introductions, product line extensions, and technology transfers into the site. This role ensures that quality requirements are effectively integrated into product and process design activities, in partnership with cross-functional teams and customers, within a contract manufacturing environment. RESPONSIBILITIES: - Provide quality engineering leadership for customer-sponsored development activities, including new product introductions, product line extensions, and technology transfers, acting as the primary quality interface for assigned programs and representing Quality in customer interactions related to development activities - Embed quality and risk-based thinking into product and process development activities by partnering with cross-functional teams and customers to ensure compliance with applicable quality standards and regulatory requirements, including leadership or support of formal risk management activities - Collaborate with Supply Chain and Supplier Quality to support supplier selection, material qualification, and supply chain readiness for development programs and transfer into manufacturing - Define and oversee quality strategies and requirements for process development, verification, validation and testing activities, ensuring alignment with quality, regulatory and customer needs - Provide structured quality risk and compliance input (as applicable) to the NPD/NPI stage-gate process - Provide quality input to product and process changes during development and transfer, ensuring changes are appropriately assessed, documented, and controlled - Support structured and controlled transfer of products and processes into operations, maintaining continuity of quality oversight through early production whilst clearly transitioning ownership to Operations Quality. - Contribute to the development and standardization of Design Quality practices, frameworks and tools, providing technical leadership, coaching, and mentoring as required within the Quality Engineering team Skills Quality engineering, Root cause analysis, Capa, Quality control, Iso 13485, Audit, Quality management system Top Skills Details Quality engineering,Root cause analysis,Capa,Quality control,Iso 13485,Audit,Quality management system Additional Skills & Qualifications Required - Bachelor's degree in a scientific, engineering or related technical discipline - Minimum 7 years of experience in Quality Engineering within a regulated manufacturing environment - Strong understanding of applicable quality standards and regulatory requirements e.g. ISO 13485, FDA 21 CFR 820, FDA 21 CFR 210/211 - Proven experience supporting new product introductions, product line extensions, and/or technology transfers - Practical experience applying risk-based quality principles to development, validation, and transfer activities - Experience representing Quality within cross-functional project teams, including customer-facing interactions Preferred - Experience working in a Contract Manufacturing Organization (CMO) or comparable environment delivering development or technology transfer activities on behalf of customers - Exposure to formal NPD/NPI governance models (e.g. stage gate reviews) Competencies - Proven ability to influence and collaborate with cross-functional teams - Excellent communication, coaching and problem-solving skills - Highly organized and diligent - Acts as a role model for quality culture Experience Level Intermediate Level Job Type & Location This is a Contract position based out of Dallas, TX. Pay and Benefits The pay range for this position is $45.00 - $52.00/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 Dallas,TX. Application Deadline This position is anticipated to close on Jun 16, 2026. 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.