Change Control Engineer - Part-Time, Elyria

Invacare; Elyria (OH); On-site; USD 34,000 - 55,000; Part time

Job summary

Invacare in Elyria, OH is seeking a part-time Change Control Specialist to manage the CC process from request through closure, including documentation and approvals. You will collaborate with global and North American teams, ensure regulatory alignment, and monitor dates and packages.

The role requires an associate degree and 3 years of engineering design/support experience, plus familiarity with FDA medical device regulations, SAP, and MS Office.

Qualifications

• Associate degree preferred in business administration or related field.
• Three (3) years engineering design/support experience.
• Working knowledge of Change Controls and impact on products/processes.
• FD A medical device regulations knowledge preferred.
• Working knowledge of Invacare products and SAP modules is a plus.

Responsibilities

• Oversee the Change Control process from request creation through closure.
• Assist CC procedure owners in training personnel on CC processes and forms.
• Coordinate with North American personnel to achieve CC goals.
• Monitor cycle-time and identify impediments or barriers.
• Ensure CC packages meet regulatory and internal procedures.
• Perform MRP data entry, including bills of material.
• Complete required training for the position.

Skills

Communication skills

Time management

Attention to detail

Team collaboration

Problem solving

Education

Associate's degree in business/PM or related

Tools

Microsoft Word

Microsoft Excel

Microsoft Access

SAP modules

Job description

Invacare in Elyria, OH is seeking a part-time Change Control Specialist to manage the CC process from request through closure, including documentation and approvals. You will collaborate with global and North American teams, ensure regulatory alignment, and monitor dates and packages.

The role requires an associate degree and 3 years of engineering design/support experience, plus familiarity with FDA medical device regulations, SAP, and MS Office.