QMS Document Control & Training Coordinator

Dornier MedTech; Northern (KY); Hybrid; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

Disability Insurance

401(k) match

Paid holidays

Education reimbursement

Job summary

Dornier MedTech is seeking a detail‑oriented professional to manage the document control process for the QMS, including training matrices and distribution of training materials to ensure regulatory compliance.

The role supports cross‑functional teams and requires experience with ISO 13485, 21 CFR 820, and EU MDR document control. Competitive benefits are offered in a full‑time capacity.

Qualifications

• Bachelor’s degree in related field or equivalent experience in medical device industry.
• Strong ability to learn and interpret regulatory procedures (FDA, EU MDR, Health Canada).
• Excellent technical writing and documentation skills.
• Experience with eQMS, document control software, and LMS preferred.

Responsibilities

• Review and obtain approval of quality system documentation (quality manual, procedures, work instructions, forms, SOPs) and maintain electronic/hardcopy files.
• Administer document numbering, revision history and approval workflows for controlled documents per ISO 13485, 21 CFR 820, EU MDR.
• Assist in regulatory submissions to US FDA and Health Canada.
• Maintain document control metrics, audits, and training records to ensure compliance.

Skills

Technical writing

Regulatory knowledge

Cross-functional collaboration

Attention to detail

Education

Bachelor’s degree in related field

Tools

Adobe Acrobat

Microsoft Office

Sharepoint

eQMS software

Learning Management System (LMS)

Job description

Dornier MedTech is seeking a detail‑oriented professional to manage the document control process for the QMS, including training matrices and distribution of training materials to ensure regulatory compliance.

The role supports cross‑functional teams and requires experience with ISO 13485, 21 CFR 820, and EU MDR document control. Competitive benefits are offered in a full‑time capacity.