What You Can Expect

Responsible for executing document control and records management processes and for ensuring records are processed retained and updated appropriately. 

How You'll Create Impact

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

What Makes You Stand Out

• Action oriented, drives for and achieves results.
• Must be proficient in MS Office and Sharepoint.
• Strong bias for coaching and mentoring others. This includes ability to effectively train team members within a class-room or workshop setting.
• Proven strong writing and editing skills.
• Proven excellent attention to detail and proofreading skills.
• Strong organizational skills and the ability to multi-task.
• Strong and effective communicator (written and verbal).
• Motivated and proven ability to work in a team-oriented, global environment, including interacting effectively with all levels and outside contacts.
• Excellent problem identification and solving skills.
• Sound decision making skills, solid under pressure.
• Effective process development and process management skills.

Your Background

• BS/BA in engineering, business, life sciences or a similar discipline required.
• Minimum of 1 – 3 years of experience in a Quality Control, Quality Assurance or Compliance roles, preferably in a document control or function in the medical device or life sciences industry.
• Working Knowledge of 21CFR Parts 11 and 820, including ISO 13485 QMS.
• Experience with electronic Document Management (eDM) systems is preferred.
• Prior experience of participating in compliance audits or inspections is preferred.

• YoE Change control experience, and when possible within the Windchill platform.

   

Physical Requirements

Travel Expectations

up to 15% 

Hybrid mode 3 days on-site in WARSAW IN.

Salary Expectations: 

$51,000-$63,000 USD