Quality Assurance Specialist- 27553

Job Description

Job Description

Our client, a Global Medical Device Manufacturer, has an immediate opening for a Quality Assurance Specialist for a 9 Month+ contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

The contractor in this role will support the implementation and validation of replacement Product Lifecycle Management (PLM) system, including data and records migration from the legacy PLM platform and seamless integration with the Manufacturing Execution System (MES).

This is a project-based role focused on computer system validation (CSV) including documenting user requirements, supporting PLM configuration, and developing User Acceptance Testing (UAT) and GxP system validation deliverables. The role plays a critical part in ensuring compliant, high-quality system adoption and a successful go-live.

1st Shift (CST) - Can be remote/hybrid

Key Responsibilities

• Reviewing existing QMS documentation to identify areas impacted by the new PLM system.
• Updating, rewriting, and reorganizing documents to align with revised PLM workflows, system capabilities, and quality requirements.
• Ensuring all changes comply with applicable regulatory, quality, and internal standards.
• Collaborating with process owners and subject matter experts to ensure accuracy and clarity of documentation updates.
• Ensuring updates across related QMS documents are implemented consistently and supporting documents remain aligned.
• Navigating the change control process to facilitate the timely release of system changes before the "go live' date.
• Partnering with the project team to understand new or updated PLM system functionalities.
• Translating system behaviors and process flows into clear, user-friendly documentation.
• Assisting in creating UAT test scripts and defining acceptance criteria based on future-state processes.
• Supporting the execution of UAT by documenting test results, identifying defects, and tracking their resolution.
• Collaborating with functional leads to validate that system behavior aligns with business requirements.
• Developing or enhancing training materials, including job aids, quick reference sheets, SOP walk-throughs, and slide decks.
• Creating clear, task-based instructions to guide end users through new PLM processes and system features.
• Working with training teams and SMEs to validate the accuracy and usability of training materials.
• Supporting onboarding and training sessions by capturing feedback and providing necessary clarifications.
  

What you need

• Bachelor's degree in science, engineering, business, or a related discipline.
• Proven experience updating and maintaining QMS documentation in a regulated environment.
• Familiarity with PLM systems and ability to translate system behaviors into clear documents.
• Strong technical writing skills with meticulous attention to detail.
• Experience supporting UAT activities, including creating test scripts and tracking defect resolution.
• Excellent communication and collaboration skills, capable of working cross-functionally.
• Ability to manage multiple tasks independently in a fast-evolving environment.
• Experience working in a regulated environment such as cGMP, cGDP, or under 21 CFR part 11.
• Stakeholder communication and customer service expertise.
• Prior experience in healthcare, medical devices, or a similar regulated industry.