Quality Engineer (NCS/Job/ 2560)

Quality Engineer, QMS will be primarily responsible for Trainings management, Doc Control process, and procedures, and ensure they are compliant, effective, and efficient in dealing with quality issues. The Quality Engineer, QMS will have through expertise in problem solving methodology, facilitate proactive and effective resolution of issues.

Furthermore, the Quality Engineer, QMS will manage Trainings management process and manages documents in onePLM and has good level of expertise with onePLM and SLMS

Roles & Responsibilities

• Manage end-to-end SLMS activities such as Curriculum creation, curriculum management, learner assignment, assessment setup, and training reporting.
• Maintain training records in the SLMS to ensure accuracy, completeness, and regulatory compliance.
• Troubleshoot system issues, coordinate with IT/SLMS support teams, and drive enhancements.
• Review and Approve Training plans.
• Generating Reports for tracking KPI's. Generate training dashboards, completion reports, overdue metrics, and compliance KPIs.
• Analyze training effectiveness and recommend continuous improvements.
• Manage controlled documents through OnePLM, including creation, routing, review, approval, release, and archival.
• Ensure documentation accuracy, version control, metadata integrity, and timely workflow completion.
• Maintain document change workflows in compliance with Quality Procedures.
• Support authoring teams with document formatting, GDP adherence, and template usage.
• Monitor document lifecycle metrics such as pending approvals, overdue changes, and revision statuses.
• Manage user access rights in OnePLM as per trainings assigned.
• Provide training and guidance on document control procedures.
• Review and approve QMS changes in onePLM
• Manage user access rights in OnePLM as per trainings assigned.
• Provide training and guidance on document control procedures.

Desired Characteristics

• 3+ years of experience within the medical devices, engineering, manufacturing, or related field required in a regulated industry.
• Working knowledge of, and experience with the following regulations/standards preferred:
  • 21 CFR Part 820
  • MDSAP
  • ISO standards (e.g., ISO 13485:2016, ISO 14971:2019)
• Experience in Internal Audits and Quality Management Systems.
• OnePLM Windchill experience (Mandatory)
• SLMS experience (Mandatory)
• Candidates with working experience in Trainings management and Doc Control
• Experience working in Medical Devices, Pharmaceuticals, or other regulated industries.
• Knowledge of Good Documentation Practices (GDP).
• Ability to interpret quality procedures related to training and competence.
• Proficiency in data reporting tools (Excel, Power BI) is an advantage.
• Strong communication, stakeholder management, and project coordination skills.