Document Control Specialist - Administrative Assistant

Job Description

Job Summary

This role is pivotal in maintaining the highest standards of product quality and regulatory compliance. The ideal candidate has document control, project management, and/or high-level administrative experience. The position involves extensive record-keeping to ensure regulatory documentation is maintained and retrievable.

Primary Responsibilities

Quality Management System (QMS) – This system complies with medical device regulations under U.S. FDA and Health Canada (including any new regulatory agencies). Regulatory changes and internal process changes, CAPA’s are managed by QA and Document Control via Document Change Orders (DCO’s) and Engineering Change Orders (ECO’s), as applicable. The ideal candidate manages the process(es) involved with upkeep and changes associated with the QMS. In addition, the Document Control Specialist actively participates in annual regulatory audits and quality meetings.

Product Development & Improvements – Will assist Engineering in managing new product development and improvements/updates to existing products, via the ECO process. Includes collaboration with other departments, as needed. Projects range from minor updates through major new product development.

Customer Feedback – The Document Control Specialist manages customer solicited and unsolicited feedback, including complaint handling and trending.

Instruction for Use/Operation Manuals – Manages end-user information materials via the ECO process: labeling, manuals, start guides, technical guidelines, videos, etc.

Approved Vendors – Manages list of approved vendors, conducts annual vendor reviews and obtains current regulatory certifications, as applicable.

Non-conformance – Will assist Production Engineering with logs, trending reports and disposition of non-conformances.

Training (QMS) – Will facilitate and ensure that required QMS training is provided and maintained for company staff.

Reporting – Will generate required reports for role as needed.

Qualifications

Intermediate-level knowledge of Microsoft Word and Excel, Adobe Acrobat/Illustrator/Photoshop, Windows Explorer

Proficiency with NetSuite or other ERP

Strong organizational and analytical skills

Experience with ISO 9001 or ISO 13485 would be helpful to haveCompany Description

ASI Dental Specialties ( is a small growing business based in the south Denver metro area near E470 and Peoria. We design and manufacture unique, innovative dental delivery equipment and sell worldwide. Our production performs final assembly, quality verification, and shipping. Vendors perform all painting, machining, and fabrication, allowing us to keep a clean, quiet, and modern facility. We engineer and develop new product technologies while using our adept internal marketing team to generate sales.

You Matter and Can Grow with Us

We are a small yet growing company. Each one of our staff is vital to fulfilling our processes. As we grow, we can provide career flexibility to learn and perform new tasks or add additional responsibilities to your position. Our innovative and custom-configured product line is challenging and purposeful.

Pride and Integrity

Due to our products' high quality and advanced designs, dental professionals highly recommend them. Our product helps many in need, and we donate our products to charitable organizations around the world that provide dental care to those who would go without it if not for having that service. You can be proud of what we make and the company you represent.

Positive Team Culture

We have a great staff that works hard and take pride in what they do. We do not have drama or egos, and all want to work together to accomplish similar objectives for our customers. You can enjoy coming to work.

Full-time