Confluent⠀Medical⠀Technologies⠀is⠀dedicated⠀to working⠀collaboratively⠀with our⠀customers,⠀taking⠀their⠀projects⠀from rapid⠀prototype⠀into high⠀volume⠀production.⠀Our⠀unparalleled⠀technical⠀expertise,⠀proven⠀experience⠀and⠀partnership⠀with our⠀clients⠀has⠀allowed us⠀to perfect⠀the⠀process⠀necessary⠀to deliver⠀world-class⠀medical⠀devices⠀through⠀innovative⠀material⠀science,⠀engineering,⠀and⠀manufacturing.⠀Our⠀primary⠀capabilities⠀include:⠀Nitinol⠀components,⠀balloon⠀expandable⠀stents and⠀balloon⠀catheters,⠀delivery⠀systems,⠀biomedical⠀textiles,⠀access⠀kits, and⠀guidewires.⠀We take⠀pride in⠀our⠀position⠀as the⠀leader in⠀the⠀medical⠀technology⠀space and⠀are driven⠀by a⠀passion to⠀create⠀products⠀that our⠀clients⠀have⠀envisioned⠀for their⠀customers.
We’re⠀looking⠀for a⠀Quality⠀Assurance⠀Engineer⠀II to join⠀our team.⠀As a⠀uniquely⠀qualified⠀candidate,⠀you will:
- Maintain⠀CAPA files⠀and⠀coordinate⠀CAPA⠀investigation,⠀root cause⠀analysis,⠀corrections,⠀corrective⠀actions to⠀prevent⠀reoccurrence,⠀and⠀effectiveness⠀of the⠀CAPA⠀System.
- Responsible⠀for⠀Confluent⠀customer⠀communication⠀and to⠀process⠀customer⠀communications/requests/complaints⠀and make⠀assignments⠀to⠀Complaint⠀Handling⠀system,⠀Equipment⠀Returns⠀(RMAs), or⠀route⠀requests⠀to⠀customer⠀solutions.
- Provide⠀guidance⠀and⠀generate⠀reports⠀for topics⠀involving⠀statistical⠀analysis,⠀including⠀sample⠀size⠀requirements,⠀hypothesis⠀testing,⠀regression⠀analysis,⠀calculation⠀of⠀confidence⠀/⠀tolerance⠀intervals,⠀and Design⠀of⠀Experiments⠀(DOE)
- Perform⠀customer⠀specification⠀change⠀request⠀reviews⠀for⠀internal⠀capabilities,⠀process⠀exceptions⠀back to⠀customer⠀for⠀finalization⠀of⠀specification⠀approval.⠀Perform⠀new⠀product⠀contract⠀and⠀specification⠀review⠀approvals⠀in ERP and⠀Quality⠀Management⠀SW⠀systems.
- Review⠀Customer⠀Complaints⠀files and⠀coordinate⠀complaint⠀investigation⠀assignment⠀and follow⠀up on⠀progress.
- Develop⠀quality⠀assurance⠀specifications,⠀test⠀methods,⠀sampling⠀plans and⠀related⠀written⠀procedures.
- Recommends⠀modifications⠀of⠀existing⠀quality or⠀production⠀standards⠀to achieve⠀optimum⠀quality⠀within⠀limits of⠀equipment⠀capability.
- Support⠀Quality⠀Control⠀inspection⠀for⠀continuous⠀improvement,⠀resolve⠀inspection⠀issues,⠀customer⠀documentation⠀and⠀certification⠀corrections⠀from⠀customer⠀complaints.⠀Qualify⠀and⠀implement⠀document⠀changes⠀involving⠀product or⠀process⠀changes.
- Support⠀manufacturing⠀and⠀process⠀Non-conformance⠀(NCR)⠀processing⠀for⠀medical⠀products &⠀coordinate⠀root cause⠀analysis,⠀reporting⠀of⠀Non-Conforming⠀Products,⠀Customer⠀Complaints⠀and Return⠀Products.
- Provide⠀quality⠀engineering⠀support to⠀quality⠀control⠀and⠀provide⠀guidelines⠀on⠀inspection⠀methods⠀and⠀equipment⠀used⠀including⠀measuring⠀systems⠀capabilities.
- Generate⠀metrics⠀and⠀monitor⠀product⠀nonconformance⠀trends in⠀order to⠀alert⠀senior⠀management⠀of these⠀trends so⠀corrective⠀action⠀plans can⠀be⠀evaluated.
- Complete⠀projects⠀in a⠀manner of⠀consistent⠀with⠀corporate⠀objectives.
- Work⠀with the⠀Manufacturing,⠀Sales and⠀Marketing,⠀Research⠀and⠀Development⠀functions⠀to⠀coordinate⠀pilot⠀balloon⠀and⠀extrusion⠀production⠀of new⠀process⠀validations⠀and risk⠀analysis⠀(FMEA) for⠀site⠀development⠀projects.
- Support⠀product/line⠀extension⠀projects⠀involving⠀risk⠀analysis,⠀Master⠀validation⠀plan,⠀product V⠀& V,⠀Process⠀Validations⠀and⠀transfer⠀design to⠀manufacturing.
- Develop,⠀implement⠀and⠀provide⠀technical⠀support of⠀Quality⠀Plans.
- Performing⠀other⠀Quality⠀related⠀tasks as⠀needed.
- Mathematical⠀Skills:⠀Ability to⠀work with⠀mathematical⠀concepts⠀such as⠀probability⠀and⠀statistical⠀inference,⠀and⠀fundamentals⠀of plane⠀and solid⠀geometry⠀and⠀trigonometry.⠀Ability to⠀apply⠀concepts⠀such as⠀fractions,⠀percentages,⠀ratios,⠀and⠀proportions⠀to⠀practical⠀situations.
- Reasoning⠀Ability:⠀Have the⠀ability to⠀define⠀problems,⠀collects⠀data,⠀establishes⠀facts, and⠀draw valid⠀conclusions.⠀Ability to⠀interpret⠀an⠀extensive⠀variety of⠀technical⠀instructions⠀in⠀mathematical⠀or diagram⠀form and⠀deal with⠀several⠀abstract⠀and⠀concrete⠀variables.
- Follows⠀all safety⠀and⠀production⠀standard⠀operating⠀procedures.
- Responsible⠀for⠀ensuring⠀personal⠀and⠀company⠀compliance⠀with all⠀Federal,⠀State,⠀local and⠀company⠀regulations,⠀policies⠀and⠀procedures⠀for⠀Health,⠀Safety and⠀Environmental⠀compliance.
Education and Experience:
- Must have⠀a degree⠀in science⠀or⠀engineering⠀and at⠀least 3-6⠀years of⠀experience⠀in Quality⠀Assurance⠀and⠀Quality⠀Engineering.
- Must⠀be⠀self-motivated⠀&⠀multi-task⠀oriented.⠀Must also⠀have⠀excellent⠀technical,⠀written⠀and verbal⠀skills and⠀be highly⠀organized.
- Knowledge⠀of product⠀development,⠀process⠀optimization,⠀and⠀failure⠀analysis,⠀FMEA, Risk⠀Analysis,⠀and⠀Verification/Validation⠀activities.
- knowledge⠀in⠀international⠀standards⠀and FDA⠀Regulatory⠀codes
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