MIFAMED MEDICAL PRIVATE LIMITED
Location
Ahmedabad | India
Job description
DUTY STATION: Mifamed Medical, Ahmedabad, India
Section/Department: QA
Title: QA, Assistant/Officer - Medical Devices
DEPARTMENT MISSION
To function as a filter at all levels to ensure that our
products supplied are of good quality along with
supporting documents that fulfil the current quality
standards and individual requirements of our customers.
PURPOSE OF POSITION
Act as QA assistant/office, responsible to assess and pre-
qualify manufacturers and products related to Medical
device as well as other activities relating to co-
ordination, performance of Internal audits & QA related
tasks.
REPORTS TO
QA/QC Manager, India
MAIN DUTIES/RESPONSIBILITIES
Review and approval of product documentation in share
point.
1. Undertake the necessary discussions and
explanations with the manufacturer with reference
to product query.
2. Collect and assess documentation and samples
needed for product approval included but not
limited to product questionnaire, product
specifications, release criteria, stability studies.
3. Assist in review of medical device with reference to
layout approval and COA review
4. Assist in continuous improvement of quality
management system to ensure better
harmonization of pre-qualification status, regulatory
activities and procurement activities.
5. Perform desktop evaluations of product and plants
as applicable
6. Verification of ISO/CE and other certificates for its
authenticity with certificate issuing body.
7. Coordinate with QA claims, deviations, root cause,
product review & retesting.
8. Coordinate with MP DK, purchase, sales in any issue
related to products, client/ manufacturer on
quotations.
9. Ensure a constructive dialogue with medical device
manufacturers related to product range, ISO
13485/MDR compliance and product file level.
QUALIFICATIONS AND COMPETENCES
Education:
Master/Bachelor degree in Pharmaceutical/Engineering
(Biomedical) or equivalent
Work experience:
2 - 4 years of experience in Medical Devices especially in
QA/QC/Production/Regulatory department at devices
supplier/ manufacturer or in a multispecialty hospital.
Preferably experience from an international company.
Competences:
On hands experience with ISO 13485 standards, EU
MDR standards, CE guide to handle the product
related issues.
Good knowledge of national and international,
quality management systems.
Excellent verbal and written technical
communication skills in English
Well structured, detail oriented, efficient with ability
to follow up and communicate results.
Should be able to review documents such as stability
studies, manufacturing processes and product
specifications, certificate verification.
Should be able to enter a dialogue with the
manufacturer for product specific evaluation.
Ability to use current job-related computer software
and databases with proficiency in Microsoft Office
package, in particular Word, Excel and PowerPoint,
is required.
Should be self-dependent of character and able to
put forward any issues needed in order to ensure a
sufficient product quality
Ability to establish harmonious work relationship
with all colleagues in an international and
multicultural environment.
Languages:
Proficiency in English
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