Overview CTG's long-standing Fortune 500 client of over 15 years has a W2 contract assignment for a Quality Engineer II.

Type: Contract Job Title: Quality Engineer II Location: Woodland, CA Candidates must be able to commute and work onsite in Woodland, CA Pay Rate: $44.43 to $58.24/hour Work Hours: M–F 8am–5pm Education: Bachelor’s degree in Science, Engineering, Bioengineering, or related field (Chemistry or Biology preferred)

Description The Quality Engineer II will develop and support all Quality Management System (QMS) and Regulatory Affairs (RA) activities in alignment with site quality goals and metrics. This role is responsible for new product setup, quality project management, and ensuring regulatory compliance for serum products. The position will ensure compliance with in-house and external specifications and standards such as cGMPs, 21 CFR 820, ISO 13485, and Quality System Procedures.

Requirements • Ensure compliance with new and changing regulations impacting products and processes, including QSR’s and global import/export regulations • Manage new product setup and related projects • Support supplier audits as needed • Collaborate with USDA on regulatory compliance, including approvals, import/export compliance, traceability, quarantine, safety testing, and affidavits • Serve as a resource for customer regulatory and technical inquiries • Maintain ISO 13485-based quality system • Implement and manage CAPA (Corrective and Preventive Actions) and problem resolution • Lead quality documentation, nonconformance reports, inspection activities, and product disposition • Review and revise procedures, specifications, and forms to maintain and improve the QMS • Act as the Quality Help Desk and customer complaint contact for problem resolution, questionnaires, certificates, and surveys • Perform internal audits in support of internal requirements, 21 CFR 820, and ISO 13485 compliance • Represent the organization in customer quality audits, supplier quality audits, and regulatory inspections • Conduct investigations and analyses to resolve quality issues • Collaborate with cross-functional teams to support quality system implementation • Create new product master files to meet customer and quality system requirements • Ensure compliance with company policies and departmental procedures, including product performance verification, problem investigation, process improvements, and non-conformance prevention • Provide training on quality systems and applicable regulations • Track and trend QMS metrics • Perform other duties as assigned

Required Qualifications

Education • Bachelor’s degree in Science, Engineering, Bioengineering, or related field (Chemistry or Biology preferred)

Qualifications • Minimum 3 years’ experience in Quality or Regulatory, preferably in medical device, pharmaceutical, or biotechnology industries • Strong knowledge and application of Quality Systems Regulations 21 CFR 820 and ISO 13485 • Ability to develop, update, and train on SOPs • Experience performing internal/external audits • Ability to monitor QMS activities, including Change Control, CAPA, Complaints, and Nonconforming Materials/Products • Problem-solving skills for investigations and root cause analysis • Experience with Continuous Improvement, Lean, or Six Sigma

Desired Qualifications • SAP, EtQ, and/or PeopleSoft experience • Statistical analysis experience • Project management experience • Knowledge of animal by-product import/export regulations • Background in animal health, virology, immunology, or epidemiology

Soft Skills • Strong organizational, time management, and attention to detail skills • Excellent interpersonal and communication abilities • Ability to work independently and influence others in a collaborative team environment

Additional Information • No third party resumes will be accepted • Drug testing and/or other employment-related inquiries may be conducted • CTG will consider for employment-qualified applicants with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws • All interested individuals MUST be able to work on a W2 Tax basis (no C2C or third party vendors) • CTG is an Equal Employment Opportunity employer • CTG is an E-Verify Company

To be considered for this opportunity, please apply directly through our website by clicking the link below or email your Word version resume and salary expectations to Rebecca.Olan@ctg.com .

The expected base salary for this position ranges from $44.43 to $58.24/hour. Salary offers are based on relevant skills, training, experience, education, market factors, and applicable licensure or certifications. In addition to salary, a competitive benefits package is offered.