Change Control Specialist

Job Title: Change Control Specialist

Location: Portage, MI

Hours/Schedule: 8am- 5pm Mon-Fri - Hybrid, 2-3 days/wk on-site

Type: Contract, Potential for extension or conversion to permanent

Responsibilities

As a Change Control Specialist, you will manage and execute complex Engineering Change Notices (ECNs) in our PLM System for Surgical Technologies to support various business and engineering activities. You will also:

• Create complex changes within the PLM System to ensure data, documents, content and information submitted in the change is accurate and compliant.
• Collaborates with the necessary stakeholders as needed to build, complete and monitor the Implementation Plan as well as the ECN.
• Facilitate and organize the Change Implementation Board (CIB) when required.
• Act as a subject matter expert in the Change Management/Change Control process as well as the onePLM system.
• Responsible for following the Change Management/Change Control process and procedures effectively within our Quality System.
• Collaborate with stakeholders across several business functions providing excellent customer service while creating and routing complex changes in our Quality System.
• Collaborate with relevant functional groups to mentor and coach teams and stakeholders through the change control process and the workflow within onePLM.
• Under minimal supervision, works with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to ensure project success.
• May act as the Change Owner as well as the Change Analyst II on changes.

Requirements

• This position requires knowledge that is acquired through experience, specialized education or training.
• The job requires a basic understanding of work routines and procedures in own discipline.
• The job is expected to follow detailed and defined rules / instructions and to make simple judgement in straightforward situations.
• Typically requires selecting between solutions already established.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.