The Quality Engineer I will be responsible for supporting and improving Quality Management System (QMS) processes to ensure compliance with FDA, ISO, customer, and company requirements within a Contract Development and Manufacturing Organization (CDMO) environment. This position partners with Manufacturing, Operations, Validation, Regulatory Affairs, Supply Chain, R&D, and customers to drive quality initiatives, investigate nonconformances, execute CAPAs, support audits, and improve manufacturing processes for medical device, pharmaceutical, biologic, or combination products.
Duties are as follow:
Maintain compliance with FDA Quality System Regulation, cGMP requirements, ISO 13485, ISO 9001, and applicable customer requirements.
Support and execute Quality Management System activities including CAPA, nonconformance management, change control, risk management, deviation investigations, and complaint trending.
Review and approve quality records to ensure accuracy, completeness, and regulatory compliance.
Participate in internal, supplier, customer, and regulatory audits and support audit responses and corrective actions.
Assist in the development, review, and implementation of SOPs, work instructions, forms, and quality procedures.
Lead investigations involving nonconforming materials, manufacturing deviations, customer complaints, and quality system issues.
Utilize root cause analysis methodologies including 5 Why, Fishbone, Is/Is Not, Fault Tree Analysis, and Failure Mode and Effects Analysis (FMEA).
Develop, implement, and verify CAPAs to prevent recurrence of quality issues.
Analyze quality trends and recommend process improvements based on data-driven findings.
Partner with Manufacturing and Engineering teams to improve product quality, process capability, and operational efficiency.
Support process validations, equipment qualifications, and manufacturing transfers.
Participate in change control reviews and assess quality and regulatory impacts.
Monitor manufacturing quality metrics and facilitate continuous improvement initiatives.
Perform risk assessments and facilitate risk management activities throughout product lifecycle stages.
Establish and monitor quality KPIs and quality metrics.
Support Lean Manufacturing and Six Sigma initiatives.
Identify opportunities to streamline processes while maintaining compliance and product quality.
Serve as a quality representative during customer meetings and project activities.
Assist with supplier qualification, audits, and supplier corrective actions.
Support customer quality agreements and quality-related communications.
Provide technical guidance regarding quality requirements and expectations.
Education:
Bachelor's degree in Engineering, Quality, Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Manufacturing Engineering, Industrial Engineering, or a related scientific discipline.
Experience:
3-5+ years of quality engineering experience in a regulated manufacturing environment.
Experience in a Medical Device, Pharmaceutical, Biotech, Combination Product, or CDMO environment strongly preferred.
Experience supporting FDA inspections, ISO audits, and customer audits preferred.
Knowledge of FDA 21 CFR Part 820, FDA 21 CFR Parts 210/211, ISO 13485, ISO 14971, cGMP requirements, Statistical process control and quality tools
Experience with: CAPA systems, Nonconformance management, Root cause investigations, Change management systems, Risk assessments, Data analysis and trend reporting, Proficient in Microsoft Excel, Word, PowerPoint, and quality management software.
Preferred certification:
ASQ Certified Quality Engineer (CQE)
ASQ Certified Quality Auditor (CQA)
Six Sigma Green Belt or higher
Lead Auditor Certification (ISO 13485 or ISO 9001)
Job Type & Location
This is a Contract position based out of Dallas, TX.
Pay and Benefits
The pay range for this position is $30.00 - $38.00/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 Jul 31, 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 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.
