Quality Certification Specialist

Full Time
Fort Wayne, IN 46825
Posted
Job description
Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce.

Job Scope:
Prepares shipping document packages and certification for a variety of customers according to each customer’s requirements. Prepares completed device history records for shipment to outside scanning service vendor. Is flexible with shift start and stop times to accommodate/prioritize workload to meet deadlines. Has the ability to work overtime as the workload demands. Has a basic understanding of blueprints. Effectively communicates with peers and interdepartmental personnel maintaining a cohesive team environment. Assists with other clerical functions upon supervisor or managerial request.

Principal Accountabilities:
  • Prepare Certificate of Conformance for each shipment in accordance with each customer’s requirement.
  • Gather and prepare material certificates and vendor certificates for each shipment of product in accordance with customer requirement.
  • Prepare completed DHR’s for scanning process and input location into the storage location software.
  • Assist in the creation and maintenance of electronic C of C Forms.
  • Orders and maintains inspection department office supplies.
  • Maintain very low customer complaints regarding document errors
  • Regular attendance is required with overtime as needed.
Experience and Training Required:
  • High School Diploma or GED required.
  • 2-3 years related experience preferred.
  • Detail-oriented
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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