Stryker NC CAPA Specialist in Phoenix, Arizona

Requisition ID 17621BR

Job Title NC CAPA Specialist

Group Global Quality and Ops

Division SGS Quality Assurance

Business Unit QA NA South

Business Function Quality Assurance

Country United States

State/Province AZ

City Phoenix

Employment Category Full Time

Percent Travel Required Up to 10%

Shift 1st

About Stryker

Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Job Description / Information

Position Summary:

Thispositionisresponsible forensuringall Phoenix-based GQONonconformanceandCAPAprojectsare compliant to Stryker'sNC/CAPA

programrequirements.

Essential Job Duties & Responsibitlies:

  • Coordinate Stryker's Non-conformanceprogram, including:

  • Actingas site SubjectMatter Expert forRootCause Analysis

  • Chairing theNonconformanceReview Boardmeetings

  • LeadNC/CAPA Team inmonthlymeetings

  • Assist/InterfacewithNCownerson Investigations,ActionPlans,and Verification/ValidationActivities

  • AssureproperRootCause Analysis forallNon-conformances

  • Monitor Problem Statements,Containment,RCA,Corrections/CAs/PAs, time lines,andrequiredupdates

  • EnsureallNC filesare:established,maintained in a timely &organizedmanner,welldocumented,and closedproperly

  • Identify & trendappropriate metricsandpresentdefinedreports.

  • Aid inauditsandaudit support.

  • Conduct supplieraudits,asneeded.

  • Support QualityAssurance inanyadditionalactivitieswithin thedepartment.

  • Other duties as assigned or apparent.

Minimum Qualifications

  • Bachelor'sDegree inrelatedor complimentary field toquality

  • Knowledgeof FDA &ISOregulationsrequired

  • ExpertwithRootCause Analysistechniquesandapplicationof those techniques

  • Certified Auditor aplus

  • ASQCertifications aplus

  • Ability toworkwith individualsacrossall levelsof theorganization,includingmanagementand customers

  • Strongwrittenandoral communication skills

  • Excellentdata collection,managementandreportingskills

  • Manage timeandresourceseffectively thoroughgoodorganizational skillsand thoroughuseofpositiveproblem solvingskills.

All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

Stryker is an EO employer – M/F/Veteran/Disability