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Quality Systems Specialist

6.00 to 8.00 Years   Gurugram   04 May, 2021
Medtronic
Job LocationGurugram
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

Position Title:Quality System Specialist- Post Market Surveillance, Gurgaon Careers that Change LivesResponsible 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.Job Responsibilities :QUALITY

    • Responsible for implementation, handling and addressing routine Quality compliance systems and processes related to Post Market Surveillance (PMS), Complaints Handling, Field Actions, Training, Vigilance Reporting, Reports Preparation, Training and provide inputs towards their effective resolution in collaboration with relevant counterparts.
    • Track and Trend product operational Field Actions & Complaints arising in Indian from various stakeholders (EOC, SBU s, employees, distributors, customers, etc.) and coordinate with counterparts/stakeholders.
    • Track and follow-up all quality training programs assigned to individuals across all departments (as applicable).
    • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
    • Monitor the performance and health of PMS processes to mitigate risk.
    • Execute policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
    • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of companys mission globally.
    • Effective control of documents by proper distribution and archival in database.
Must Have- Minimum Requirements:
  • Must have at least 6-8 years relevant Post Market Surveillance (PMS) 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.
  • Knowledge and competency in application of FDA, ISO 13485 and other regulatory requirements especially in the area of Quality Systems 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
PHYSICAL REQUIREMENTS:The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.ABOUT MEDTRONICTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We can accelerate and advance our ability to create meaningful innovations but we will only succeed with the right people on our team. Let s work together to address universal healthcare needs and improve patients lives. Help us shape the futureAdditional Information
  • Posting Date: Apr 30, 2021
  • Travel: No
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Keyskills :
regulatory requirementspost market surveillancequality compliancecommunication skillsquality assurance systemsquality systemsiso 13485written communicationtraining programsquality assurancemusic making

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