Project Coordinator

Integer•Plymouth, MN

About The Position

At Integer, the company culture is unified by a common set of values: Customer, Innovation, Collaboration, Inclusion, Candor, and Integrity. These values are embedded in everything the company does. The Project Coordinator role involves compiling and ensuring the quality of documents for CR submission, tracking CR progression, and maintaining a CR log for R&D associates. The position requires adherence to Integer’s Values and all safety, environmental, security, and quality requirements, including QMS, FDA regulations, company policies, and operating procedures.

Requirements

Bachelor’s Degree or commensurate experience
3-5 Years Minimum Experience
Reliance or similar ERP system knowledge (3-5 years of experience)
Microsoft office products knowledge (3-5 years of experience), comfortable with Excel spreadsheets
Excellent written and communication skills able to communicate to multiple organization levels
Highly organized with the ability to work independently and within a team

Nice To Haves

Manufacturing experience preferred

Responsibilities

Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
Compiles documents submitted by R&D associates for CR submission
Ensures the documents & attachments meet minimum requirements (correct templates, proper formatting, etc.) and compiles with governing quality documents before submitting
Work with doc control team to make sure any additional corrections necessary before changes can route for approval
Clearly communicate issues with submissions to requesters as needed
Tracks CR progression and follows up with approvers on a regular basis to facilitate timely release of CRs
Creates and maintains a CR log for R&D associates to easily track CR closures and communicate reasons for delay or rejection
Other duties as assigned

Benefits

Base salary
Cash-based incentive program supporting our pay-for-performance philosophy
Comprehensive benefits package with immediate eligibility
Medical insurance
Dental insurance
Vision insurance
Disability insurance
Life insurance
Adoption benefits
Parental leave (available after one year)
Optional employee-paid supplemental life insurance
Optional employee-paid critical illness insurance
Optional employee-paid hospital indemnity insurance
Optional employee-paid accident insurance
Immediate eligibility to participate in the 401(k) plan with company matching contributions
80 hours (10 days) of company designated holidays per year
Annual allotment of paid time off