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
Employment Category Full Time
Percent Travel Required Up to 10%
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
Thispositionisresponsible forensuringall Phoenix-based GQONonconformanceandCAPAprojectsare compliant to Stryker'sNC/CAPA
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.
Support QualityAssurance inanyadditionalactivitieswithin thedepartment.
Other duties as assigned or apparent.
Bachelor'sDegree inrelatedor complimentary field toquality
Knowledgeof FDA &ISOregulationsrequired
ExpertwithRootCause Analysistechniquesandapplicationof those techniques
Certified Auditor aplus
Ability toworkwith individualsacrossall levelsof theorganization,includingmanagementand customers
Strongwrittenandoral communication skills
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