Medtronic Project
Coordinator III/ Executive - Quality Assurance, pharma/medical device/life
science industry
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:
o Maintain the Quality Management System (QMS)
QA in compliance with Medtronic India (QMS) & ISO13485 standards.
o Responsible 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.
o Works directly with operating entities to
provide process analyses oversight on a continuing basis to enforce requirements
and meet regulations.
o Execute 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.
o Streamlining the process and follow-up (as
required) quality training programs assigned to individuals across all
applicable departments.
o Facilitates uniform standards worldwide and
enables best practice sharing, thereby fostering the achievement of company's
mission globally.
o Ensures all corrective action and preventive
actions (CAPAs) or audit findings (if any) are completed on time for job area.
o Effective control of documents by proper
distribution and archival in database.
o Establish & 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.
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