Position: Quality Engineer
Location: MA, CA, TX, NJ, MN
Duration: 12+ Months | W2 – Contract

POSITION SUMMARY:

The Quality Engineer will play a critical role in supporting quality systems and compliance activities for biologics, medical devices, pharmaceutical, and combination products. This role focuses on ensuring alignment with regulatory requirements (FDA, EMA, etc.), supporting manufacturing quality, and driving documentation excellence throughout the product lifecycle. The candidate will collaborate cross-functionally with R&D, MS&T, Supply Chain, Regulatory, and Commercial teams.

REQUIRED SKILLS & EXPERIENCE:

• Minimum 5 years of quality experience in a biologics or pharmaceutical manufacturing environment.
• Strong background in manufacturing or quality control of biologics; experience with process qualification protocols and process validation documents is essential.
• Proficient in reviewing and managing quality documentation including batch records, method validation, and deviation reports.
• Working knowledge of TrackWise, Veeva, SAP, or Oracle inventory systems is highly desirable.
• Hands-on experience supporting PPQ (Process Performance Qualification) and validation lifecycle activities.
• Familiarity with applicable regulatory standards including FDA cGMP, ICH Q guidelines, and ISO for combination products.
• Strong communication and collaboration skills to work effectively across multiple teams and stakeholders.

EDUCATION:

• Bachelor’s degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Biotech, Quality Engineering).
• Advanced knowledge of quality systems and compliance requirements within the biologics/pharmaceutical industry.
  Job Type: Contract
  Pay: $42.09 - $50.69 per hour
  Work Location: In perso

• Ensure integration and compliance with quality regulations related to biologics, drugs, medical devices, and combination products.
• Review and support the development, approval, and implementation of quality system documentation, including process qualification and validation protocols.
• Provide quality assurance oversight for manufacturing processes, including batch record review, document control, and deviation handling.
• Support regulatory inspections (FDA, EMA, ANVISA, etc.) and internal audits by preparing relevant quality data and documentation.
• Coordinate and implement quality system elements such as design control, training programs, CAPA, and continuous improvement initiatives.
• Participate in new product introduction (NPI) and design changes for biologics and combination products.
• Interact with internal stakeholders and external partners to enhance quality systems, promote best practices, and ensure audit readiness.
• Evaluate processes for compliance gaps and drive corrective actions to ensure robust and compliant quality systems.
• Provide strategic support to Product QA, Manufacturing QA, Supplier QA, and other quality functions to meet business and regulatory objectives.
• Ensure compliance from raw material inspection through final product release, with emphasis on process qualification and validation.