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CooperCompanies · 2 months ago

Quality Assurance Specialist II

11160 Warner Ave #411 (Moving to suite #253 in November), Fountain Valley, CA, 92708, US

Full-time

Onsite

Mid Level

CooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting patients at critical healthcare moments. The Quality Assurance Specialist II is responsible for developing and maintaining Quality System processes, training personnel, and partnering with stakeholders to enhance the quality program within the organization.

Medical Device

Responsibilities

Maintain and develop Quality procedure(s)

Review and approve production lots for release

Generate and analyze data for tracking and trending

Work with stakeholders to provide continuous improvement

Train the organization on Quality System(s) and Quality procedures

Mentor less experienced team members

Drive change to prevent and remediate risks to internal and external customers

Qualification

Quality System processesRisk ManagementProcess MonitoringQuality Event ReportingDocument Control ProgramSupplier QualificationValidationsTraining skillsContinuous improvement mindsetCommunication skills

Required

Experience in Quality Assurance or Quality Management

Strong written and verbal communication skills

Ability to foster cross-functional collaboration and partnerships

Experience in training personnel on Quality Systems

Knowledge of Risk Management, Production Lot Release, Process Monitoring, Quality Event Reporting, Document Control Program, Supplier Qualification, and Validations

Ability to drive change to prevent and remediate risks to internal and external customers

Mentoring experience with less experienced team members

Strong continuous improvement mindset

High level of integrity

Company

CooperCompanies

CooperCompanies (Nasdaq: COO) is a leading global medical device company focused on helping people experience life’s beautiful moments through its two business units, CooperVision and CooperSurgical.

Founded in 1958