Reports?to:?Technical?Quality?Manager
BASIC?QUALIFICATION
??Minimum?3?years’?experience?auditing?in?the?EO?sterilization?at?medical?device?industry
??Bachelor’s?degree?in?a?technical?engineering?field
??Medical?Device?Quality?System?Knowledge?Including?MDD93/42/EEC?&?ISO?13485,?ISO11135:2014
REQUIRED?COMPETENCIES
??Experience?with?CAPA,?complaint?investigation,?risk?management,?EO?sterilization?knowledge
??Excellent?written?and?verbal?communication?skills?are?essential.
??Strong?computer?skills
??Strong?organizational?and?time?management?skills
??Ability?to?review,?analyze,?summarize,?and?draw?conclusions?and?make?appropriate?recommendations?and?decisions;?write?reports;
??working?with?supplier?to?resolve?sterilization?quality?issues
KEY?RESPONSIBILITIES
??Process?audit?to?the?sterilization?process
?Execute?CAPA?and?non-conformance?tracking?to?ensure?corrective?actions?are?addressed?for?all?sterilization?activities.
??Assist?suppliers?in?developing?and?executing?sterilization?validations.
Provide?NC?and?CAPA?support?for?NCs?involving?sterilization?issues?as?needed.
?writing?and?execution?/?coordination?of?sterilization?protocol?testing?and?the?respective?final?report.
?Coordination?of?sterilization?qualification?and?requalification?activities?with?sterilization?suppliers.
?Coordinate?of?testing?of?qualification?and?requalification?activities?(bio-burden,?sterility,?residual?testing).
?Monitor,?analyze?and?drive?improvement?in?supplier?performance,?including?audit?findings?and?CAPA.
?Act?as?a?liaison?between?365?healthcare?Shermond?and?its?suppliers.
??All?other?duties?as?assigned.
??This?job?involves?domestic?travel,?up?to?20%