Quality Specialist jobs in United States
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Getinge · 10 hours ago

Quality Specialist

Getinge is dedicated to making life-saving technology accessible for more people. The Quality Specialist will ensure all documentation meets quality standards and regulatory compliance, managing the Quality Management System's documents and records.

BiotechnologyHealth CareLife ScienceMedicalMedical Device
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H1B Sponsor Likelynote

Responsibilities

Change Order Management – this role will have Document Control responsibilities, and all routed records in the QMS will need a Document Control approval
Training Assignments – Ensuring all updates with required training are appropriately assigned and completed
DHR Review and lot release
Support internal and external audits – Provide necessary documents for audits and ensure compliance
Must have strong written and verbal communication skills
Proficient with Document Management software systems

Qualification

Document ControlRegulatory ComplianceDocument Management SoftwareTraining ManagementWritten CommunicationVerbal Communication

Required

Must have strong written and verbal communication skills
Proficient with Document Management software systems

Preferred

0-3 years experience working in a regulated industry (FDA, MDR, and ISO 13485 background preferred)
Bachelor's degree preferred

Benefits

Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Commuter Benefits
Parental and Caregiver Leave
Tuition Reimbursement

Company

Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.

H1B Sponsorship

Getinge has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)

Funding

Current Stage
Public Company
Total Funding
$539.31M
2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO

Leadership Team

C
Christoffer Å.
Chief Information Security Officer
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Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
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Company data provided by crunchbase