Document Control Specialist I

Position Overview:

In compliance with FDA, European MDD/MDR & ISO regulations, the Document Control Specialist I will perform work exercising judgment with supervision. General scope of this position is to maintain product related documentation and the flow of information in the form of controlled documents and engineering change orders, over the life cycle of any given product manufactured at SWMI. This position requires frequent use and general knowledge of industry practices, techniques, and standards.

Essential Job Functions

• Maintain document change control process via engineering change control system (log, track and process DCOs, maintain material and BOM data)

• Check revised documents and completed change orders to assure the highest level of accuracy and conformance with the approved format and standards

• Review, process, and release documents using variety of software packages.

• Maintain electronic files of master active or archived documents (native source application files as well as the .pdf viewable files)

• Assist in the data entry setup of training sets for new hires that may include technical and Quality Management System procedures when needed

• Assist in the data entry of employee training records when needed

• Assist maintenance of Direct Labor Competency Assessment Records when needed

• Other duties as assigned Requirements

• Bachelor’s Degree or a high school diploma and 2 years of experience in document control in a manufacturing environment

• Experience working in the medical device industry is preferred

• Working knowledge of MS word, excel and other database systems. Knowledge of Solid Works or other draw programs preferred

• Ability to work in a fast-paced environment while managing multiple priorities

• Must have strong written and verbal skills, and be able to effectively communicate with all levels of the organization

• Operate as a team and/or independently while demonstrating flexibility to changing requirements.

• Employee may be required to lift objects up to 25lbs

About Aston Carter:

Aston Carter provides world-class corporate talent solutions to thousands of clients across the globe. Specialized in accounting, finance, human resources, talent acquisition, procurement, supply chain and select administrative professions, we extend the capabilities of industry-leading companies. We draw on our deep recruiting expertise and expansive network to meet the evolving needs of our clients and talent community with agility and excellence. With offices across the U.S., Canada, Asia Pacific and Europe, Aston Carter serves many of the Fortune 500. We are proud to be a ClearlyRated Best of Staffing® double diamond winner for both client and talent service.

Diversity, Equity & Inclusion

At Aston Carter, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email astoncarteraccommodation@astoncarter.com (%20astoncarteraccommodation@astoncarter.com) for other accommodation options.