Quality Engineer I (Gurugram, HR, IN, 122002)

Hollister Incorporated

Experience: 0+ yrs
Location: Gurugram, Haryana, India
Job type: Full-time

Required skills

Microsoft Excel
SAP
HRIS

About the role

Location- Gurugram

Summary

This role supports Global Quality and Regulatory Affairs (GQRA) operations for medical devices. The position contributes to design assurance activities, supplier and documentation quality coordination, and maintenance of the Quality Management System (QMS). The role focuses on ensuring compliance with applicable global medical device regulations and standards while supporting continuous improvement, audit readiness, and data-driven quality decision-making.

Responsibilities

• Support design assurance documentation control, routing, and tracking across assigned programs.
• Assist with Design History File (DHF) and risk management file maintenance and remediation.
• Support preparation and maintenance of quality and regulatory documentation and records.
• Contribute to data analysis, dashboards, key performance indicators (KPIs), and management review inputs.
• Support internal audit activities, including preparation, tracking of actions, and follow-up.
• Assist with nonconformance, CAPA, and QMS documentation updates under guidance.
• Collaborate with cross-functional stakeholders to support quality compliance and operational effectiveness.

Essential Functions of the Role

Communicate effectively via email, phone, and virtual platforms.
Maintain and analyze data using tools like Excel, SAP, or HRIS systems.
Prepare reports and dashboards for internal stakeholders.

Education & Work Requirements

Bachelor's Degree with no previous professional experience

Education & Work Preferences

• 0–2 years of relevant professional experience; entry-level candidates are eligible.
• Foundational knowledge of medical device quality systems and regulations (e.g., ISO 13485, FDA 21 CFR Part 820, EU MDR).
• Proficiency with basic data analysis tools such as Microsoft Excel; familiarity with quality systems or reporting tools is beneficial.

• Master’s degree or advanced coursework in a relevant discipline.
• Prior exposure to medical device quality, regulatory, or design assurance activities.
• Experience with quality management systems, document control tools, or data visualization platforms.
• Ability to manage multiple tasks with attention to detail in a regulated environment.
• Willingness to travel up to 10% as needed.

Competencies

Be Agile - Innovates and adapts quickly, approaching change with curiosity while persisting through obstacles.
Be Customer Centric - Considers the needs, experiences and feedback of customers in all we do.
Be People-Focused - Builds trust and collaborates with an inclusive and empathetic approach.
Be Performance Driven - Operates with an ownership mindset, driving meaningful outcomes.
Live The Schneiders’ Legacy, Our Noble Purpose - Passionately serves Our Mission and Vision, while demonstrating the Immutable Principles.
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Location- Gurugram

About Hollister Incorporated

Develops and manufactures specialized ostomy and continence healthcare products.

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