6 days old

Project Coordinator III/ Executive - Quality Assurance, Gurgaon

Project Coordinator III/ Executive - Quality Assurance, Gurgaon


Gurgaon, Haryana, India

Requisition #:


Post Date:

5 days ago

**Careers that Change Lives**

This is the time to join Medtronic, the worlds leading medical technology and solutions company. Medtronic is committed to improving the lives of patients worldwide. We are present in more than 160 countries have an annual revenue of $29.7 billion. The way the world accesses and interacts with the healthcare ecosystem is changing, and you have an opportunity to shape things in your location. You will have an opportunity to disrupt the status quo, collaborate and take on healthcares greatest challenges all while continuing to deliver on our Mission to alleviate pain, restore health and extend life. Come help us drive the transformation of healthcare. Join a Leader be a leader.

**Main Purpose:**

Responsible for establishment implementation of robust Operations Quality compliance systems in Medtronic. Also responsible for ensuring that effective Quality Assurance systems, programs and processes are in place.

**Key responsibilities:**

oMaintain the Quality Management System (QMS) QA in compliance with Medtronic India (QMS) ISO13485 standards.

oResponsible for implementation, handling and addressing routine Quality compliance systems and processes related to Corrective preventive Actions (CAPA), BIS Registration, Change Management, Audit observations closure, Supplier Management, Training as per local regulatory requirements. Also, provides inputs towards their effective resolution in collaboration with relevant counterparts.

oWorks directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

oExecute process deliverables by interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Follow the guidelines set by corporate to Prepare quality procedures/reports related to QMS performance required for management review.

oStreamlining the process and follow-up (as required) quality training programs assigned to individuals across all applicable departments.

oFacilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

oEnsures all corrective action and preventive actions (CAPAs) or audit findings (if any) are completed on time for job area.

oEffective control of documents by proper distribution and archival in database.

oEstablish promotes a work environment that supports the quality policy and quality system.

**Must Have:**

Must have at least 2 to 6 years relevant QA experience in the pharma/medical device/life science industry.

Experience in Quality systems implementation and maintenance; GMP/Quality Systems Regulations; ISO 13485 is a plus.

**Nice to Have**

Easily communicate with colleagues, management and external authorities

Be able to plan, manage, organize and report in an efficient way

Be independent, persuasive, innovative and able to summarize

Excellent verbal and written communication skills in English
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.


Posted: 2020-03-24 Expires: 2020-04-26

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