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Quality Regulatory Internship

Getinge Group

Seattle, WA

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JOB DETAILS
JOB TYPE
Intern, Full-time
SKILLS
Artificial Intelligence (AI), Biology, Biomedical Engineering, Cardiovascular Intensive Care Unit (CVICU), Clinical Outcomes, Code Reviews, Code of Federal Regulations, Computer Software, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Data Storage, Detail Oriented, FDA (Food and Drug Administration), Follow Through, Hospital, ISO (International Organization for Standardization), ISO 9001, Internal Audit, Microsoft Excel, Microsoft Outlook, Microsoft Word, Operations Processes, Organizational Skills, Presentation/Verbal Skills, Procedure Development, Project Evaluation, Project/Program Management, Quality Engineering, Quality Management, Regulations, Risk Analysis, Root Cause Analysis, Sales, Software Development, Software Validation, System Validation, Team Player, Time Management, Vendor/Supplier Evaluation, Writing Skills
LOCATION
Seattle, WA
POSTED
30+ days ago
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.

Job Overview

Getinge USA is looking for a Quality Engineer Intern to support the following activities:

Quality plan involvement and active participant in Corporate Internal Audit finding resolution activities for data/record storage and migration.

Aid, and potential lead, aspects of project for supplier evaluation and remediation activities.

Support Corrective and Preventive Action (CAPA) activities potentially including: Risk Analysis, Root Cause Analysis, Action Implementation, and Verification of Effectiveness.

Computer Software Validation (CSV) project management and implementation of software validation activities including:

Software retirement reporting

Software periodic reviews

Developing software validation procedures.

Internal audit support

The intern will gain experience in:

Project management for FDA and ISO regulated quality management system processes

Career experience in internal audit settings

Invaluable experience with CSV and knowledge of how software is used in FDA regulated settings

Experience with CAPA activities

Experience with ISO 13485: 2016, ISO 9001: 2015, and 21 CFR 820 regulations and standards

Critical experience on applying a risk based approach to meaningful work

Minimum Qualifications and Experience

Must be pursuing a undergraduate or graduate degree in Engineering, Biomedical or related field.

Intermediate skills in Word, Excel, Outlook required. Experience with AI tools preferred.

Ability to work approximately 35 hours/wk.

Previous experience with ERP systems preferred.

Demonstrated analytic and problem-solving skills.

Excellent organizational and time-management skills

Solid written and verbal communications skills

Attention to detail and accuracy

Strong follow through and accountability

Pay Rate: $21 - $23 / hour

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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.

Getinge is an equal opportunity employer. Getinge will, at all times, will comply with all applicable human rights and other legislation when considering all qualified applicants for employment. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Getinge is an equal opportunity employer M/F/Veteran/Disability All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status

About the Company

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Getinge Group