Senior Quality System Specialist (Hybrid) at Stryker

São Paulo, State of São Paulo, Brazil

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Inglês avançado
Experiência prévia com não conformidade e CAPAs
Conhecimento da RDC 665/22 e ISO 13485:2016
Experiência prévia em Medical Devices
Experiência em realizar auditorias
(Desejável) Conhecimento do sistema Trackwise
(Desejável) Experiência em administrar treinamentos
(Desejável) Conhecimento em Espanhol

Responsibilities

Responsável por atividades de Contenção de Estoque, Ações de Campo e Reportes as autoridades sanitárias baseado na RDC 551/21 ou qualquer outra que venha a substituir
Realizar auditorias internas, de provedores e canais indiretos
Participar ativamente de auditorias externas, como inspeções sanitárias, auditorias Inmetro, auditorias de certificação e auditorias corporativas
Elaborar e revisar documentos relacionados a PMS e NC/CAPA
Ministrar treinamentos
Participar ativamente para compilação e/ou construção de indicadores de Qualidade relacionados a PMS e NC/CAPA
Identificar oportunidades de melhoria contínua e executar ações
Atender a métricas de desempenho, conforme estabelecido em objetivos de Qualidade

Skills

Key technologies and capabilities for this role

NC/CAPAPMSRDC 551/21RDC 665/22ISO 13485:2016Auditorias InternasAuditorias ExternasTrackwiseMedical DevicesInglês Avançado

Questions & Answers

Common questions about this position

What is the work arrangement for this role?

The position offers a hybrid work flexibility.

What are the mandatory requirements for this position?

Mandatory requirements include advanced English, prior experience with non-conformities and CAPAs, knowledge of RDC 665/22 and ISO 13485:2016, experience in Medical Devices, and experience conducting audits.

Is travel required for this role?

Yes, the role involves 20% travel.

What salary or compensation does this position offer?

This information is not specified in the job description.

What desirable skills would make my application stronger?

Desirable skills include knowledge of the Trackwise system, experience in administering trainings, and knowledge of Spanish.

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Medical & prescription plans

Supplemental health benefits

Flexible Spending accounts

Employee Assistance Program

Short-term & long-term disability

Tuition reimbursement

401(k) plan

Employee Stock Purchase Plan

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

Land your dream remote job 3x faster with AI

Try Jobo Free