Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegene’s high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

Must Have

Associate – Quality Assurance-Design Control Lab Engineer

You will be responsible for:
• Lab Test Method Validation and Transfer plans, protocols, and reports handling
• Lab testing protocols and reports
• Lab Test Requests handling
Development, drafting review and maintenance of Design History Files (DHFs) related artefacts including but not limited to Design inputs
• Design verification plans
• Design verification protocols and reports
• Design and development plans
• Risk analysis
• Feasibility plans, protocols and final reports etc
Development and review of risk management plans, reports, FMEAs;Ensure FMEA’s are performed as required to mitigate risks in design, transfer, and manufacturing
Performing gap assessment for DHF remediation and reporting out the findings
Your impact:
About you:
Strong working knowledge of ISO 13485:2016 and/or 21CFR 820
Strong understanding of risk-based approach per ISO 14971
Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field.
Strong flair and passion for technical writing. Excellent technical & med device product documentation skills
Strong written and verbal communication/presentation skills
Must have:
Bachelor's degree (B.E. B.tech)
Minimum 3 years of experience in any of the following functions—medical device development/regulatory-medical writing/developing/publishing medical content

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.