Senior Executive Quality Analyst

Job Title: Senior Executive Quality Assurance & Compliance
Experience: 2-4 years
Location: Noida

About the Role:
We are seeking a proactive and detail-oriented professional to join our Quality Assurance (QA) team as a Senior Executive QA & Compliance. The ideal candidate will have experience in quality management systems, regulatory compliance, and audit coordination. This role offers the opportunity to contribute to maintaining and improving our high standards in quality assurance while working with a globally renowned medtech organization.

Key Responsibilities

1. Documentation for Quality Management Systems (QMS):

• Prepare and manage documentation for QMS standards in compliance with ISO 13485:2016, ISO 14001:2015, ISO 45001:2018, EU MDR 2017/745, MDD 93/42/EEC, and other regulatory requirements.

2. Audit Support:

• Actively participate in third-party audits conducted by Notified Bodies, customers, and regulatory entities.
• Collaborate with cross-functional teams to ensure adherence to regulatory and quality requirements during audits.

3. Internal Audit Coordination:

• Coordinate and support internal audit activities as per the defined schedule.
• Work closely with internal teams to ensure timely execution and closure of audits.

4. Change Control Assistance:

• Assist in managing change control processes and maintaining related logs.
• Provide support in ensuring all change control activities are documented and tracked.

Qualifications and Skills

• Education: Bachelor's degree in Science, Engineering, or related fields (preferably in Life Sciences or Pharmaceuticals).

• Experience: 2-4 years of experience in Quality Assurance, preferably in the medical devices or healthcare industry.

• Technical Skills:
• Knowledge of QMS standards like ISO 13485, ISO 14001, and ISO 45001.
• Familiarity with EU MDR 2017/745 and MDD 93/42/EEC regulations.
• Experience in audit preparation and regulatory compliance.

• Soft Skills:
• Strong coordination and communication skills.
• Excellent attention to detail and organizational abilities.
• Ability to work collaboratively in a cross-functional environment.

Why Join Us?

• Be part of a globally recognized medtech company that values innovation, excellence, and growth.
• Work in a dynamic and collaborative environment with opportunities for professional development.
• Contribute to creating high-quality healthcare solutions that impact lives worldwide.