Document Control Specialist

Join a high-performing group with a purpose: to grow a safer, cleaner, healthier future for everyone, every day.­­

We are hiring for Document Control Specialist in Halma company MST

Location - Bengaluru

Business Unit - Healthcare

Report to - Sr. Quality Systems Manager

We are simple, humble and approachable, and we believe in leadership at all levels to bring our purpose to life. Everyone at Halma India makes an impact, and so do you when you join us

About us

Halma is a global group of life-saving technologies companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US

Our diverse group of nearly 50 global companies specialise in market leading technologies that push the boundaries of science and technology.

For over 50 years, the combination of our purpose, strategy, people, DNA and sustainable business model has resulted in record long-term growth in revenues and profits and an increase in dividend by ≥ 5% every year– an achievement unrivalled by any company listed on the London Stock Exchange.

We have a team of over 250 professionals representing commercial, digital and support functions across our seven offices in India, two in Bengaluru and one each in Delhi, Mumbai, Thanjavur, Vadodara, and Ahmedabad.

HALMA INDIA IS CERTIFIED AS A GREAT PLACE TO WORK.

Here's why working with us is fulfilling:

We offer a safe and respectful workplace, where everyone can be who they 'REALLY' are, feel free to bring their whole selves to work and use their unique talents, knowledge, expertise, experiences, & backgrounds to create meaningful outcomes.

We nurture entrepreneurial spirits and empower them to think beyond the possibilities, to discover, shape and build their own unique stories. Our diverse businesses and operations provide fulfilling opportunities to grow as individuals and make an impact.

Detailed job description

About Halma company MST

MST's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. It is our relentless pursuit of addressing our customers' needs that creates a profound customer preference. We strive to equip surgeons with the most innovative tools, enabling them to achieve the best possible outcomes for the patients. We constantly evolve to meet the distinct clinical needs of ophthalmic surgeons through our dedicated partnership with surgeon-designers, bringing innovation to ophthalmology. Expanding our offerings into excisional goniotomy, we now market micro-instruments used for adult and infantile glaucoma, which improve the health and livelihood of patients by providing a safe and effective surgical intervention.

MST- https://microsurgical.com/

Position Objective

The Document Control Specialist is responsible for the administration and control of documents and records within the Quality Management System (QMS), ensuring compliance with applicable regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR). This position supports change control, elements of configuration management, and lifecycle control of design and manufacturing documentation. The role requires high attention to detail, strong organizational skills, and a deep understanding of document and change control principles in a highly regulated environment.

Responsibilities

• Manage the full lifecycle of controlled documents including creation, review, approval, release, revision, obsolescence, and archival.
• Ensure documentation complies with internal procedures and regulatory standards.
• Administer the electronic Quality Management System (eQMS), including maintaining metadata, audit trails, workflows, and user permissions.
• Share primary ownership of document & change control, as well as training administration.
• Provide controlled documents in support of internal and external audits, ensuring document readiness and traceability.
• Coordinate and process change orders in accordance with company procedures and regulatory expectations.
• Ensure change documentation is complete, accurate, and reviewed/approved by appropriate stakeholders.
• Monitor and support implementation of approved changes.
• Assist in the maintenance of configuration control of product documentation throughout its lifecycle (e.g., Design History Files, Device Master Records).
• Maintain and organize records in accordance with regulatory retention requirements and internal policies.
• Ensure accessibility, security, and legibility of both electronic records during their required retention periods.
• Serve as key user or administrator for the eQMS both from a document & change control standpoint, as well as training management.
• Train and support users in document control and change control processes and system usage.
• Identify and support process improvement initiatives related to document and configuration management.
• Support the creation and revision of ERP-controlled items such as part numbers, BOMs, and routers.
• Collaborate with cross-functional teams to ensure ERP changes are implemented accurately and consistently with documentation changes.
• Enter and validate data in ERP changes related to change orders.
• Performs other duties as necessary.

Critical Success factors

• Minimum 3 years of experience in document control and/or configuration management in a highly regulated industry (e.g., medical device, pharmaceutical, aerospace).
• Knowledge of FDA QSR, ISO 13485, and document control principles.
• Experience with eQMS and ERP platforms. Master Control and Infor Syteline is highly desirable, but other similar systems would be considered acceptable.
• Experience in using Project/Task Management Software is preferred. Click Up is highly desirable, but other similar systems (e.g., Jira, Asana, Monday, etc) would be acceptable.
• Prior experience assisting in internal and external audits is preferred.

Academic qualification

• Bachelor's degree in a technical, business, or administrative discipline, or equivalent experience.

Experience

• Minimum 3 years of experience in document control and/or configuration management in a highly regulated industry (e.g., medical device, pharmaceutical, aerospace).

Key attributes

• Strong skills in using Microsoft Word, especially with understanding how to use its complex document formatting features.
• Experience in using Microsoft Teams, or other similar software such as Slack.
• Strong organizational skills, attention to detail, and ability to manage multiple document workflows.
• Strong communication (both written and oral) and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Demonstrated ability to work independently, prioritize tasks, and manage multiple projects simultaneously.
• Proven high aptitude for adoption of technology and ability to configure a software environment.

Competencies

• Detail-oriented and well-organized, with the ability to manage multiple tasks and priorities simultaneously.
• Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
• Excellent English oral and written communication with precise attention to detail.
• Strong work ethic, self-motivated, team player with strong interpersonal skills.
• Strong analytical, problem-solving, and project management skills.