Quality Engineer

Job Description

Job Description

The Quality Engineer provides dedicated quality engineering support for customer-sponsored development activities, 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 within a contract manufacturing environment, partnering closely with cross-functional teams and customers to maintain compliance with applicable quality standards and regulatory requirements.

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.
• Represent the Quality function in customer interactions related to development activities, ensuring clear communication of quality expectations and status.
• Embed quality and risk-based thinking into product and process development by partnering with cross-functional teams and customers to ensure compliance with applicable quality standards and regulatory requirements.
• Lead or support formal risk management activities to identify, assess, and mitigate risks throughout development and transfer phases.
• Collaborate with Supply Chain and Supplier Quality teams 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 to the NPD/NPI stage-gate process, supporting effective governance of development projects.
• Provide quality input to product and process changes during development and transfer, ensuring changes are appropriately assessed, documented, and controlled.
• Support the structured and controlled transfer of products and processes into operations, maintaining continuity of quality oversight through early production.
• Clearly transition quality ownership to Operations Quality while ensuring that appropriate controls and documentation are in place.
• Contribute to the development and standardization of Design Quality practices, frameworks, and tools across the organization.
• Provide technical leadership, coaching, and mentoring within the Quality Engineering team to promote best practices and a strong quality culture.
• Apply quality engineering tools such as root cause analysis, CAPA, and quality control methods to drive continuous improvement and issue resolution.
• Support internal and external audits and contribute to maintaining an effective quality management system in line with ISO and regulatory requirements.

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.
• Strong understanding of applicable quality standards and regulatory requirements, including ISO standards, FDA 21 CFR 820, and 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.
• Hands-on experience with quality engineering tools such as root cause analysis, CAPA, and quality control.
• Experience working with and maintaining a quality management system and supporting audits.
• Ability to interpret and apply quality and regulatory requirements to product and process design.
• Strong problem-solving skills with the ability to investigate issues and implement effective corrective and preventive actions.

Additional Skills & Qualifications

• Experience working in a Contract Manufacturing Organization (CMO) or a comparable environment delivering development or technology transfer activities on behalf of customers.
• Exposure to formal NPD/NPI governance models, such as stage-gate processes.
• Ability to influence and collaborate effectively with cross-functional teams.
• Excellent communication skills, with the ability to convey complex quality and regulatory concepts clearly to diverse stakeholders.
• Coaching and mentoring skills to support the development of other quality professionals.
• Highly organized and diligent, with strong attention to detail and follow-through.
• Demonstrated ability to act as a role model for quality culture and promote continuous improvement.
• Familiarity with audit processes and regulatory inspections in a regulated manufacturing environment.

Work Environment

This role operates within a regulated contract manufacturing environment focused on development activities such as new product introductions, product line extensions, and technology transfers. You will collaborate closely with cross-functional teams, including Supply Chain, Supplier Quality, Operations Quality, and customer project teams, to ensure that products and processes meet quality, regulatory, and customer requirements. The position involves working within established quality management systems aligned with ISO standards and FDA regulations, participating in formal NPD/NPI stage-gate processes, and supporting risk management, validation, and testing activities. The work setting emphasizes structured processes, documentation, and continuous improvement, with a strong culture of quality, collaboration, and technical excellence.

This is a Contract position based out of Dallas, TX.

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)

This is a fully onsite position in Dallas,TX.

This position is anticipated to close on Jul 7, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 View email address on ziprecruiter.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.