Quality Engineer
Job
Actalent
Dallas, TX (In Person)
$100,880 Salary, Full-Time
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Job Description
The Senior Design Quality Engineer provides dedicated quality engineering support for development activities, including new product introductions, product line extensions, and technology transfers. This role ensures that quality requirements are effectively integrated into product and process design activities, in partnership with cross-functional teams, 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. Act as the primary quality interface for assigned programs and represent 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. 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. Provide structured quality risk and compliance input 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. Contribute to the development and standardization of Design Quality practices, frameworks, and tools. Provide technical leadership, coaching, and mentoring as required within the Quality Engineering team. Essential Skills Bachelor's degree in a scientific, engineering, or related technical discipline. Minimum 7 years of experience in Quality Engineering within a regulated manufacturing environment. Understanding of applicable quality standards and regulatory requirements such as
ISO, FDA 21 CFR 820, FDA 21 CFR 210/211.
Proven experience supporting new product introductions, product line extensions, and 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. Additional Skills & Qualifications Experience working in a Contract Manufacturing Organization (CMO) or comparable environment. Exposure to formal NPD/NPI governance models, e.g., stage gate. Strong 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. Work Environment The position operates within a contract manufacturing environment, requiring collaboration with cross-functional teams and customers. The role demands excellent communication and problem-solving skills, along with a dedication to maintaining high-quality standards. The work involves ensuring compliance with regulatory requirements and may include customer-facing interactions. Job Type & Location This is a Contract to Hire 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.
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