Quality Specialist

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screening to the transplant community.

Position Overview : The Quality Specialist will play a crucial role in ensuring all documentation meets expected standards for quality for the organization, including ensuring compliance to regulatory requirements. This role is responsible for the organization, management, and maintenance of all document and records belonging to the Quality Management System.

Primary responsibilities/authority will include:

• 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

Required Qualifications:

• 0-3 years experience working in a regulated industry (FDA, MDR, and ISO 13485 background preferred) as a document control specialist.
• Bachelor’s degree preferred

About us 

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.  

Benefits at Getinge:

At Getinge, we offer a comprehensive benefits package, which includes:

• 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

Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.