Supplier & Operations Quality Engineer
Full-timeSeniorQuality AssuranceAesthetics and Eye CareUnknownMasters
Market Rate — Compliance Officers
25th
$59K
Median
$76K
75th
$101K
BLS 2024 data (national)
Description
Lumenis is a global leader in energy-based solutions for Aesthetics and Eye Care. We are looking for a Supplier & Operations Quality Engineer for the QA team. The role includes covering all quality aspects related to production, process control and improvement, data collection and analysis, quality investigations and training/qualification sessions to production at sub-contractors, support QA transfer to production from development stages, and support QA transfer of production sites (TK & FTK). Main duties include supporting quality activities, ensuring the quality of deliverable parts/materials, data collection and analysis, incoming inspections, product final release activities, review and approval of e-DHR conversion activities, leading quality meetings, and supporting non-conforming material control among others.
Requirements
Quality education - CQM or CQE Or Master's degree. Minimum of 5 years of experience in Quality. Experience with multidiscipline products & medical devices. Ability of approving test protocols and V&V. Knowledge in Process Validation, pFMEA. Knowledge of product Life Cycle methods and control, medical standards/regulations such as ISO13485, FDA – QSR, MDD/MDR, IEC 60601, GMP. Familiar with failure analysis and statistical techniques. Proficient in English. Multi-tasking and good interpersonal relationship.
Lumenis
BIOTECHNOLOGY
Energy-based medical treatments
LocationAustralia - Chatswood
Employees1001-5000
Open Jobs18
UnknownOphthalmologyAestheticsMedical DevicesAesthetics and Eye Care
View Company ProfilePipeline
triLift systemN/A
Protection of eyes with tinted soft scleral eye shieldsN/A
Phototherapy treatmentN/A
High energyN/A
cameraN/A