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Document Control Analyst

Natus Neuro -
Bengaluru, Karnataka

Apply Now

Job details

Full-time
8 days ago

Benefits

Health insurance
Paid time off
Work from home

Qualifications

IT service management
English
ISO 9001
Analysis skills
Project management
Diploma
Communication skills
FDA regulations
Product lifecycle management

Full job description

Welcome to Natus Sensory India
We are continuing to grow our business in India and are now looking to expand our team there. Be part of this exciting journey right from the start!

Natus Sensory India are a leading manufacturer of medical devices and software for a range of solutions, including eight sensory nervous systems. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. We manufacture and distribute a range of medical device products used in the diagnosis of human disorders of sensory system and neural pathways.

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.

Compensation and Benefits: Along with a competitive salary and performance-based incentives, we offer a comprehensive benefits package starting from day one, including medical insurance coverage for employees and their families, gratuity as per statutory norms, and paid time off in accordance with applicable labor laws.

Join Natus Sensory today. Confidence in every Sense.

We offer:

The role will start as a work-from-home remote position but will turn into a physical presence in an office role in Bangalore.
Minimal travelling: less than 5%
Collaborative and international environment with different cultures.
English company language.
Full ownership of testing of features and functionality.

EEO Statement
Natus Sensory is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.

Apply Now

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