Administrator.Eng Change. (Part-time)

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

Job Details: Job Location: Elyria, OH 44035, (Part-Time Position)

Essential Functions:

• Oversee the Change Control (CC) process and activities for assigned products from creation of CC request through implementation of requirements and CC closure, including authoring, assigning approvers, checking the CC package for completeness and accuracy, data entry, distribution of any or all portions of the CC documentation, and monitoring of effective dates.
• Assist CC procedure owners in training personnel on the CC process, supporting documentation, and forms associated with the procedures and any associated open protocols.
• Work closely with all levels of North American personnel involved in the CC process to assist in the timely execution of CC goals and objectives and help develop their CC knowledge.
• Monitor cycle-time capabilities of global affected departments for the identification and communication of impediments or barriers.
• Understand the contents and scope of each CC package with regards to level of impact on global departments/facilities/people and the ability to communicate intent of request to affected Change Review Boards.
• Assist CC originators/assignees in the determination of appropriate supporting paperwork and instructions to complete the CC documentation and package. This includes assisting in the determination of affected global facilities/departments to ensure inclusion in the change plan, assisting in proper documentation of changes made per the change plan, and assisting in gathering effective dates from affected global facilities/departments on the implementation plan contained in the CC package.
• Review all CC packages to ensure all legal, regulatory (US and Canada), and established procedures have been followed prior to final CC approvals.
• Perform MRP data entry, including bills of material.
• Complete all required training applicable to assigned position.
• Exhibit positivity, flexibility, creativity, and a willingness to take on new responsibilities as requested or required.

Qualifications:

• Associate’s degree in business administration, Project Management or related field preferred
• Three (3) years engineering design/support experience.
• Working knowledge of different types of Change Controls and the effect the changes have on products, processes, or other areas of the business.
• Working knowledge of manufacturing, product, and design related systems and how proposed changes will affect these systems.
• Working knowledge of PC/Windows applications, including but not limited to Word, Excel, and Microsoft Access.
• Working knowledge of ANSI/ISO standards and established engineering/documentation guidelines.
• Working knowledge of current Food and Drug Administration (FDA) medical device laws, regulations and practices preferred.
• Working knowledge with SAP modules a plus.
• Working knowledge of Invacare products preferred.
• Must have excellent verbal and written communication skills.
• Must have excellent time management skills.
• Must be detail oriented.
• Exceptional interpersonal/team skills include ability to effectively interact with employees at all levels.
• Effective problem-solving skills.

An Equal Opportunity/Affirmative Action Employer –M/F/Disabled/Vet