Quality Engineer II

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

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Type: Contract

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Job Title: Quality Engineer II

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Location: Woodland, CA

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Candidates must be able to commute and work onsite in Woodland, CA

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Pay Rate: $44.43 to $58.24/hour

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Work Hours: M–F 8am–5pm

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

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Description

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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.

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Requirements

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• Ensure compliance with new and changing regulations impacting products and processes, including QSR’s and global import/export regulations

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• Manage new product setup and related projects

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• Support supplier audits as needed

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• Collaborate with USDA on regulatory compliance, including approvals, import/export compliance, traceability, quarantine, safety testing, and affidavits

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• Serve as a resource for customer regulatory and technical inquiries

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• Maintain ISO 13485-based quality system

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• Implement and manage CAPA (Corrective and Preventive Actions) and problem resolution

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• Lead quality documentation, nonconformance reports, inspection activities, and product disposition

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• Review and revise procedures, specifications, and forms to maintain and improve the QMS

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• Act as the Quality Help Desk and customer complaint contact for problem resolution, questionnaires, certificates, and surveys

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• Perform internal audits in support of internal requirements, 21 CFR 820, and ISO 13485 compliance

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• Represent the organization in customer quality audits, supplier quality audits, and regulatory inspections

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• Conduct investigations and analyses to resolve quality issues

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• Collaborate with cross-functional teams to support quality system implementation

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• Create new product master files to meet customer and quality system requirements

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• Ensure compliance with company policies and departmental procedures, including product performance verification, problem investigation, process improvements, and non-conformance prevention

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• Provide training on quality systems and applicable regulations

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• Track and trend QMS metrics

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• Perform other duties as assigned

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Required Qualifications

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Education

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

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Qualifications

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• Minimum 3 years’ experience in Quality or Regulatory, preferably in medical device, pharmaceutical, or biotechnology industries

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• Strong knowledge and application of Quality Systems Regulations 21 CFR 820 and ISO 13485

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• Ability to develop, update, and train on SOPs

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• Experience performing internal/external audits

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• Ability to monitor QMS activities, including Change Control, CAPA, Complaints, and Nonconforming Materials/Products

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• Problem-solving skills for investigations and root cause analysis

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• Experience with Continuous Improvement, Lean, or Six Sigma

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Desired Qualifications

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• SAP, EtQ, and/or PeopleSoft experience

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• Statistical analysis experience

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• Project management experience

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• Knowledge of animal by-product import/export regulations

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• Background in animal health, virology, immunology, or epidemiology

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Soft Skills

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• Strong organizational, time management, and attention to detail skills

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• Excellent interpersonal and communication abilities

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• Ability to work independently and influence others in a collaborative team environment

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Additional Information

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• No third party resumes will be accepted

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• Drug testing and/or other employment-related inquiries may be conducted

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• 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

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• All interested individuals MUST be able to work on a W2 Tax basis (no C2C or third party vendors)

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• CTG is an Equal Employment Opportunity employer

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• CTG is an E-Verify Company

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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 .

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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.

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About CTG

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CTG, a Cegeka company, is at the forefront of digital transformation, providing IT and business solutions that accelerate project momentum and deliver desired value. Over nearly 60 years, we have earned a reputation as a faster and more reliable, results-driven partner. Our vision is to be an indispensable partner to our clients and the preferred career destination for digital and technology experts. CTG leverages the expertise of over 9,000 team members in 19 countries to provide innovative solutions. Together, we operate across the Americas, Europe, and India, working in close cooperation with over 3,000 clients in many of today's highest-growth industries. For more information, visit .

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Our culture is a direct result of the people who work at CTG, the values we hold, and the actions we take. In other words, our people define our culture. It's a living, breathing thing that is renewed every day through the ways we engage with each other, our clients, and our communities. Part of our mission is to cultivate a workplace that attracts and develops the best people, reflected by our recognition as a Great Place to Work Certified™ company across many of our global operations.

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CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.

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CTG is an Equal Opportunity Employer. CTG will assure equal opportunity and consideration to all applicants and employees in recruitment, selection, placement, training, benefits, compensation, promotion, transfer, and release of individuals without regard to race, creed, religion, color, national origin, sex, sexual orientation, gender identity and gender expression, age, disability, marital or veteran status, citizenship status, or any other discriminatory factors as required by law. CTG is fully committed to promoting employment opportunities for members of protected classes.