Quality Regulatory Internship

Getinge • Seattle, WA

8d • $21 - $23

About The Position

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

Requirements

• 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.
• 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

Nice To Haves

• Previous experience with ERP systems preferred.

Responsibilities

• 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

What This Job Offers

• Career Level: Intern