Actalent
Quality Assurance Engineer
Job Description:
The Quality Assurance Engineer is responsible for providing GMP, CAPA, and Quality Systems training and guidance. This role involves managing and participating in all internal and external audit programs as needed. The engineer will assist in the development and maintenance of systems to manage complaints, work with department heads to identify training needs, and act as an internal reviewer on Quality systems documentation. Additionally, the role includes ensuring compliance with the CAPA Process and monitoring the timely investigation and implementation of CAPAs and NCRs.
Responsibilities
Provide GMP, CAPA, and Quality Systems training and guidance for employees and CAPA teams by developing and delivering education and training related to complaints management and customer care.
Keep up to date with current issues regarding complaints and risks and ensure that managers are informed of developments and their implications.
Manage and participate in Quality systems activities such as GMP training for employees and coordinate training programs as needed.
Conduct audits, write audit reports, distribute reports, follow up on non-conformances, and support third-party audits.
Act as an internal reviewer on Quality systems, specifications, OOS, NCRs, Deviations, and DCA.
Assist in developing and maintaining procedures and policies for complaint management.
Evaluate complaint activities and make appropriate recommendations.
Perform complaint investigations and draft responses for leadership review.
Research, write, and edit new and existing content for procedure manuals, technical specifications, and process documentation.
Ensure compliance with cGMP, ISO, FDA, and Quality System regulations.
Monitor investigation and implementation of CAPAs and NCRs and report progress to senior management.
Identify CAPA and NCR resources and escalate requirements to senior management as needed.
Function as the Quality Assurance representative for the review and approval of CAPAs, Deviations, NCRs, Validations, and Complaints.
Maintain positive relations between Quality Assurance and other functional areas.
Essential Skills
Quality assurance
Quality engineering
CAPA
GMP
QMS
Internal audit
NCR
Quality control
Additional Skills & Qualifications
Bachelor’s degree in a related technical field or 6–8 years of work-related experience in Quality Compliance, Quality Control, or Quality Systems.
Proficient knowledge of 21 CFR Parts 820, 210, 211, ISO, and Quality Systems Regulations.
Excellent communication skills, both oral and written.
Ability to work with employees at all levels of the organization.
Ability to perform under pressure and demonstrate problem-solving and troubleshooting skills.
Lean/Six Sigma Green Belt certification is preferred.
Job Type & Location
This is a Contract to Hire position based out of Dallas, Texas.
Pay and Benefits
The pay range for this position is $40.00 - $46.00/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 Oct 31, 2025.
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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
Job Description:
The Quality Assurance Engineer is responsible for providing GMP, CAPA, and Quality Systems training and guidance. This role involves managing and participating in all internal and external audit programs as needed. The engineer will assist in the development and maintenance of systems to manage complaints, work with department heads to identify training needs, and act as an internal reviewer on Quality systems documentation. Additionally, the role includes ensuring compliance with the CAPA Process and monitoring the timely investigation and implementation of CAPAs and NCRs.
Responsibilities
Provide GMP, CAPA, and Quality Systems training and guidance for employees and CAPA teams by developing and delivering education and training related to complaints management and customer care.
Keep up to date with current issues regarding complaints and risks and ensure that managers are informed of developments and their implications.
Manage and participate in Quality systems activities such as GMP training for employees and coordinate training programs as needed.
Conduct audits, write audit reports, distribute reports, follow up on non-conformances, and support third-party audits.
Act as an internal reviewer on Quality systems, specifications, OOS, NCRs, Deviations, and DCA.
Assist in developing and maintaining procedures and policies for complaint management.
Evaluate complaint activities and make appropriate recommendations.
Perform complaint investigations and draft responses for leadership review.
Research, write, and edit new and existing content for procedure manuals, technical specifications, and process documentation.
Ensure compliance with cGMP, ISO, FDA, and Quality System regulations.
Monitor investigation and implementation of CAPAs and NCRs and report progress to senior management.
Identify CAPA and NCR resources and escalate requirements to senior management as needed.
Function as the Quality Assurance representative for the review and approval of CAPAs, Deviations, NCRs, Validations, and Complaints.
Maintain positive relations between Quality Assurance and other functional areas.
Essential Skills
Quality assurance
Quality engineering
CAPA
GMP
QMS
Internal audit
NCR
Quality control
Additional Skills & Qualifications
Bachelor’s degree in a related technical field or 6–8 years of work-related experience in Quality Compliance, Quality Control, or Quality Systems.
Proficient knowledge of 21 CFR Parts 820, 210, 211, ISO, and Quality Systems Regulations.
Excellent communication skills, both oral and written.
Ability to work with employees at all levels of the organization.
Ability to perform under pressure and demonstrate problem-solving and troubleshooting skills.
Lean/Six Sigma Green Belt certification is preferred.
Job Type & Location
This is a Contract to Hire position based out of Dallas, Texas.
Pay and Benefits
The pay range for this position is $40.00 - $46.00/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 Oct 31, 2025.
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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.