We are seeking a detail-oriented and experienced Quality Systems Validation Specialist to join our Quality team in Marlborough, MA. In this role, you will drive software validations, ensure regulatory compliance, and support process improvements within a dynamic and regulated environment. This position is critical to maintaining and enhancing our Quality Management System (QMS) and achieving key organizational goals.

Key Responsibilities:

• Software Validation:
  • Develop and execute software validations for existing software packages within the Quality System.
  • Assess and document compliance with FDA 21 CFR Part 11 as part of these validations.
  • Complete validations for six (6) software packages by year-end.
• Systems Integration:
  • Support the integration of the electronic document management system (Arena) with ERP (NetSuite) for Bill of Materials (BOM) alignment.
• Process Improvement:
  • Collaborate with the QA Manager to execute organizational and process improvements for the Return Materials Authorization (RMA) system.
• Additional Support:
  • Assist with document and manufacturing batch record reviews as needed.

Key Qualifications and Skills:

• Education and Experience:
  • Bachelor’s degree in a related technical field.
  • 2–5 years of relevant experience in a regulated industry (Medical Device, Pharmaceutical, etc.), ideally supporting a manufacturing/production site.
• Regulatory Knowledge:
  • Proficiency in 21 CFR Part 820, ISO 13485, and ISO 14971.
  • Comprehensive understanding of GDP (Good Documentation Practices).
• Technical Expertise:
  • Experience working within a compliant Quality Management System (QMS).
  • Prior use of web/cloud-based PLM/QMS platforms; experience with Arena PLM is preferred.
  • Familiarity with ERP and PLM system architecture, manufacturing documentation (e.g., item/part, BOM, MPN), and their applications.
• Software Validation:
  • Proven ability to partner with cross-functional teams (R&D, Manufacturing, Quality, IT) to execute software verification and validation strategies.
  • Skilled in developing protocols, test scripts, and risk assessments for software supporting QMS.
• Soft Skills:
  • Strong organizational and time management abilities with a track record of managing multiple priorities and delivering quality outcomes.