Quality & Regulatory Administrator in Arden, NC at Medical Action Industries

Date Posted: 5/29/2018

Job Snapshot

Job Description


Perform variety of administrative and support tasks for the quality department such as; entry of quality data into SAP, complete customer quality surveys, assist in response to customer audits, assemble and forward requested specifications and certifications, assist regulatory specialist, respond to customer questions related to product quality, and assist in preparing quality reports to Management.


1.       Serves as Quality primary point of contact for customers; makes judgements as to whether query can be answered or should be escalated to management.   Crucial gatekeeper on product and compliance information.

2.       Manages Document Control System; initiates Standard Operating Procedures (SOP) per request and ensures appropriate SOP approvals and associated training is performed.

3.       Maintains file of current product specifications, contacting suppliers as necessary for product information.

4.       Manages all authorized deviation documentation, including timely closure.

5.       Ensures customer and pre-audit surveys are accurately completed within requested time.

6.       Provides certificates of sterility and certificates of compliance for customers upon request.

7.       Assists in acquiring and maintaining regulatory attributes for products.

8.       Performs scheduled finished goods and raw material inspections in compliance with SOPs which may include the use of calibrated measuring devices.

9.       Maintains records of inspection results and maintains acceptance and rejection activities in Enterprise Resource Planning (ERP) system and in incoming inspection folders.

10.   Ensures non-conforming materials are placed on hold in accordance with SOPs and documents disposition in ERP system.

11.   Communicates product failures to Quality Assurance Management.

12.   Product inspection to Device Master Record

13.   Composes letters to customers as requested.

14.   Responds to customer questions in regards to products attributes.

15.   Assists with maintenance and storage of records including tracking of offsite storage.

16.   Assists with internal audits and recalls including database creation, maintenance, reports and correspondence as directed by Quality management.

17.   Assists in investigations and/or documentation of complaints as directed by Quality management.

18.   Maintains calibration documentation in software and hard copy files, including scheduling, printing and closing of orders.

19.   Contributes to meeting department quality goals and objectives as indicated yearly.


1.      Performs additional duties as directed.



1.       Associate's degree (A. A.) or equivalent from two-year college or technical school required

2.       Six months to one year related experience and/or training

3.       Or equivalent combination of education and experience.


1.       Requires high degree of accuracy and reasoning ability

2.    Communicates effectively, both verbally and in writing

3.    Manages time and resources effectively through strong organization, multi-tasking and time management

4.    Working knowledge of Excel (including graph and pivot table generation), Microsoft Word, PowerPoint and Access database;  SAP software proficiency very helpful

5.       Uses knowledge and experience to perform all work independently, with little or no direct supervision, and in accordance with verbal and written instructions and processes provided for guidance.


1.       None


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