Main?responsibilities：
1.?Review?of?specification?documents?(eg.?Procedure,?SOPs)?taking?into?account?the?factors?influencing?the?participating?functional?areas?(Quality,?Regulatory?Submissions,?R?&?D,?production,?QC)?and?in?accordance?with?the?regulatory?requirements.
2.?Ensure?the?output?of?design?and?development?in?accordance?with?the?GMP,?CFR?820.30,?ISO13485?and?MDR?requirement.
3.?Deliver?the?training?of?QM?Basic?Course?to?organization.
4.?Facilitate?quality?relevant?KPIs?such?as?internal?audit?and?external?audit.
5.?Coordinate?internal?audit?program,?and?ensure?that?the?processing?of?audit?CAPA?cases?carried?out?in?accordance?with?the?requirements,?including:
6.?Preparation?of?internal?annual?audit?plan
7.????Host?internal?audit?process,
8.
?????Coordinate?monthly?internal?auditor?meeting,
9.
????Coordinate?internal?audit?workshop.
10.?Support?coordinate?authority/?notify?body?Audit?essence?of?QMS?AMS,?including:
11.????Logistics?preparation?for?external?audit,
12.????Documents?readiness?checklist?and?SME?identification,
13.?Audit?CAPA?follow?up.
14.?Preparation?of?inputs?for?the?Quality?Management-Review
15.?Lead?the?monitoring?and?evaluation?on?adverse?event?according?to?NMPA?requirement.?
Requriements:
1.?At?least?10?years?QMS?experience?of?Manufacturing?and?R&D?in?medical?industrial.
2.?ISO?13485?Auditor?Certificate
3.?Knowledge?of?regulatory?and?legal?national?and?international?requirements?such?as?ISO?13485,?GMP,?NMPA?and?knowledge?of?internal?processes?and?systems,?the?medical?devices.
4.?Good?knowledge?of?English.?Excellent?communication?skills.
5.?Familiar?with?relevant?regulatory?statutes?and?industry?standards,?Experienced?with?the?principles?and?system?processes?/?tools?within?the?QA/QM?field