Actalent
Job Title: Quality Engineer IIJob Description
As a Quality Engineer II, you will work independently to initiate, investigate, and support quality events, complaints, CAPA's, and SCARS. You will coordinate and maintain the customer complaint & CAPA management system, validations for all departments, along with the Calibration and Environmental Monitoring Programs. Writing and implementing methods and procedures to support the quality management system will also be part of your role.
Responsibilities
Review and approve quality assurance procedures and reports.
Coordinate the implementation of process controls to support manufacturing operations.
Support the implementation of company initiatives.
Participate in the investigation, resolution, and prevention of product and process non-conformances.
Provide support for validations and facilitate audits (both internal and supplier).
Support compliance with applicable Regulatory Quality System standards.
Conduct root cause analysis investigations and perform risk assessments to identify appropriate corrective actions.
Conduct quality assurance tests and perform statistical analysis to assess control levels and manage product quality risks.
Employ quality engineering tools and techniques to develop, align, and optimize systems and processes.
Participate and support Tier Daily Management.
Ensure cleanliness of work areas and follow applicable safety procedures.
Essential Skills
Experience in conducting root cause analysis related to investigations and CAPAs.
Knowledge of GMP and ERP systems.
Proficiency in using a QMS.
Advanced analytical and problem-solving skills.
Experience in internal and external audits.
Technical writing skills.
Collaboration across all levels of employees.
Good interpersonal, mathematics, and communication skills.
Attention to detail, organizational skills, and the ability to prioritize workloads.
Additional Skills & Qualifications
Bachelor’s degree in a natural/life science field, preferably with experience in the medical device, biotech, or pharmaceutical industry.
3-5 years of experience in quality engineering, quality assurance, or a similar role.
Experience in creating, developing, and executing protocols, method transfers, and training programs.
Knowledge of lean methodologies.
Certified Quality Engineer (CQE)/Certified Quality Auditor (CQA) certification is preferred.
Work Environment
This position requires on-site work during standard business hours. You will work in an environment that emphasizes adherence to quality management systems and regulatory standards, using technologies such as MS Office Suite. The dress code and facility conditions align with standard professional expectations.
Job Type & Location
This is a Contract position based out of Morrisville, North Carolina.
Pay and Benefits
The pay range for this position is $37.50 - $44.00/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 Morrisville,NC.
Application Deadline
This position is anticipated to close on Oct 3, 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.
As a Quality Engineer II, you will work independently to initiate, investigate, and support quality events, complaints, CAPA's, and SCARS. You will coordinate and maintain the customer complaint & CAPA management system, validations for all departments, along with the Calibration and Environmental Monitoring Programs. Writing and implementing methods and procedures to support the quality management system will also be part of your role.
Responsibilities
Review and approve quality assurance procedures and reports.
Coordinate the implementation of process controls to support manufacturing operations.
Support the implementation of company initiatives.
Participate in the investigation, resolution, and prevention of product and process non-conformances.
Provide support for validations and facilitate audits (both internal and supplier).
Support compliance with applicable Regulatory Quality System standards.
Conduct root cause analysis investigations and perform risk assessments to identify appropriate corrective actions.
Conduct quality assurance tests and perform statistical analysis to assess control levels and manage product quality risks.
Employ quality engineering tools and techniques to develop, align, and optimize systems and processes.
Participate and support Tier Daily Management.
Ensure cleanliness of work areas and follow applicable safety procedures.
Essential Skills
Experience in conducting root cause analysis related to investigations and CAPAs.
Knowledge of GMP and ERP systems.
Proficiency in using a QMS.
Advanced analytical and problem-solving skills.
Experience in internal and external audits.
Technical writing skills.
Collaboration across all levels of employees.
Good interpersonal, mathematics, and communication skills.
Attention to detail, organizational skills, and the ability to prioritize workloads.
Additional Skills & Qualifications
Bachelor’s degree in a natural/life science field, preferably with experience in the medical device, biotech, or pharmaceutical industry.
3-5 years of experience in quality engineering, quality assurance, or a similar role.
Experience in creating, developing, and executing protocols, method transfers, and training programs.
Knowledge of lean methodologies.
Certified Quality Engineer (CQE)/Certified Quality Auditor (CQA) certification is preferred.
Work Environment
This position requires on-site work during standard business hours. You will work in an environment that emphasizes adherence to quality management systems and regulatory standards, using technologies such as MS Office Suite. The dress code and facility conditions align with standard professional expectations.
Job Type & Location
This is a Contract position based out of Morrisville, North Carolina.
Pay and Benefits
The pay range for this position is $37.50 - $44.00/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 Morrisville,NC.
Application Deadline
This position is anticipated to close on Oct 3, 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.