Document Control Analyst

Job Title: Document Control Analyst Department: QARA Location: Remote This is a fully remote position, with a possibility of working from Bangalore Office in the future. Candidates must be available during core business hours to support cross-functional collaboration and operational activities (Europe & US time zones). Company equipment and system access will be provided in accordance with IT and data security policies. Candidate must have the ability to prioritize work effectively in a remote environment.   Implements and maintains an Engineering Change Notice System. These changes will include document control changes, product improvements, repairs, and new product development. Coordinates the interaction between QA, engineering, manufacturing, field operations, and marketing to ensure appropriate changes are documented. Assign training required by Changes Orders as required.   Responsibilities:  Change Impact Analysis: Evaluate the impact of proposed changes on product safety, performance, software functionality, and compliance. Documentation & Compliance: Ensure all technical documentation (BOM, CAD, Verification/Validation reports) meet QMS requirements. Risk Mitigation: Identify potential quality risks associated with changes and develop mitigation strategies. Test Coordination: Collaborate with QA engineers to ensure appropriate regression testing is conducted before a change is implemented. Change Board Support: Prepare materials for and participate in Change Control Board (CCB) meetings. Readiness Tracking: Monitor change readiness, ensuring all stakeholders are prepared for the rollout. Process Improvement: Identify gaps in current processes and suggest improvements to increase efficiency. Monitor and analyse change control trends, quality system metrics, and process performance data. Present trending data and insights during quality review meetings and management reviews.   Required Skills & Qualifications A related Diploma/Degree in Quality or equivalent. Motivated, self-starter professional must be detail-oriented and possess the ability to multi-task. Fluent in English: Excellent communication skills. Analytical Ability: Strong technical understanding to analyse complex systems and data. Quality Management Systems (QMS): Familiarity with regulatory standards (e.g., ISO 9001, FDA regulations, MDD, MDR and MDSAP) and documentation requirements. Project Management Knowledge: Understanding of change management methodologies. Communication: Ability to work across teams (R&D, Engineering, QA) to gather information. Attention to Detail: Ability to review documentation meticulously for compliance. Technical Knowledge: Experience with Product Lifecycle Management (PLM) tools or IT Service Management (ITSM) systems.                                                   Experience Required:  Individuals at this level are fully proficient in most functional tasks and bring strong technical or professional knowledge to their role. Typically requiring 3–5 years of experience in the field, they can handle complex assignments, managing parts of larger projects, and providing technical guidance to peers. Experience should demonstrate problem-solving, collaboration, and the ability to document and present complex information clearly. Individuals must have strong communication skills and experience working remotely as part of a team.