Actalent
Quality Assurance Engineer
The Quality Assurance Engineer is responsible for providing GMP, CAPA, and Quality Systems training and guidance. The 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 related to complaints management and customer care.
Keep up to date with current issues regarding complaints and risks and ensure managers are informed of developments and 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 higher level management.
Identify CAPA and NCR resources and elevate requirements to higher level management as needed.
Represent Q‑A 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
Contract to Hire position based out of Dallas, Texas.
Pay And Benefits
Pay range: $40.00 – $46.00 per hour. Benefits include:
Medical, dental & vision
Critical Illness, Accident, and Hospital coverage
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)
Equal Opportunity Employer
Actalent is a global leader in engineering and science services 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 other characteristic protected by law.
If you would like to request a reasonable accommodation due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Application Deadline
This position is anticipated to close on Nov 4, 2025.
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Responsibilities
Provide GMP, CAPA, and Quality Systems training and guidance for employees and CAPA teams by developing and delivering education related to complaints management and customer care.
Keep up to date with current issues regarding complaints and risks and ensure managers are informed of developments and 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 higher level management.
Identify CAPA and NCR resources and elevate requirements to higher level management as needed.
Represent Q‑A 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
Contract to Hire position based out of Dallas, Texas.
Pay And Benefits
Pay range: $40.00 – $46.00 per hour. Benefits include:
Medical, dental & vision
Critical Illness, Accident, and Hospital coverage
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)
Equal Opportunity Employer
Actalent is a global leader in engineering and science services 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 other characteristic protected by law.
If you would like to request a reasonable accommodation due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Application Deadline
This position is anticipated to close on Nov 4, 2025.
#J-18808-Ljbffr