Demo

Quality Engineer

Ventura Solutions LLC
Andover, MA Full Time
POSTED ON 3/19/2025
AVAILABLE BEFORE 4/18/2025

We are seeking a skilled Quality Engineer to provide essential support our client's automation projects on a contract basis. This role involves collaborating closely with cross-functional teams, including Engineering, APO (Automation Project Owners), and Quality teams, to ensure quality compliance and successful execution of automation initiatives. The Quality Engineer will be responsible for reviewing and approving key project documents, overseeing change control processes, and supporting the development and maintenance of quality-related procedures.

Responsibilities

  • Collaborate with engineering and project teams to provide quality engineering expertise for automation projects.
  • Review and approve essential project documents, including User Requirement Specifications (URS), Functional Specifications (FS), and Configuration Specifications (CS).
  • Support the management and execution of change control processes related to automation initiatives.
  • Ensure quality compliance by reviewing and approving Standard Operating Procedures (SOPs) and other quality-related documentation.
  • Partner with cross-functional teams to identify and address quality risks, ensuring compliance with regulatory and company standards.
  • Facilitate seamless communication between engineering, APO, and quality teams to align project goals with quality requirements.
  • Participate in audits and inspections related to automation projects, providing subject matter expertise on quality processes.
  • Assist in the creation and maintenance of quality documentation to support automation projects, ensuring alignment with industry best practices.

Qualifications

  • Bachelor's degree in Engineering or Life Sciences.
  • Experience supporting automation projects in a regulated industry (e.g., medical device, pharmaceutical, biotechnology).
  • Strong understanding of quality engineering principles, including document review / approval and change control processes.
  • Ability to work closely with Automation, APO, and other Quality team members.
  • Experience in GMP manufacturing control systems and relevant infrastructure.
  • Experience in GMP and GAMP is preferred.
  • Experience with PLC / SCADA type of control systems.
  • Familiarity with regulatory standards and requirements for quality management systems.
  • Excellent communication and collaboration skills, with the ability to work effectively in cross-functional teams.
  • Detail-oriented with a focus on maintaining high-quality standards in project deliverables.
  • Experience in the medical device or pharmaceutical industry.
  • Knowledge of automated systems and related quality requirements.
  • Hands-on experience with URS, FS, CS, and change control documentation.
  • Location

  • Andover, MA
  • Employment Type

  • W2 Employee with Ventura Solutions
  • 5-month contract
  • Benefits

  • Choice of medical, dental, and vision plans.
  • Paid vacation time
  • About Ventura Solutions

    Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at

    Equal Opportunity Employer Minorities / Women / Veterans / Disabled

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