Quality Assurance Specialist, QMS & Audits

Demant; Eden Prairie (MN); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, prescription, and  ve

24/7 virtual medical care

Employee Assistance Program for you &/

401(k) with company match

Company-paid life insurance

Supplemental insurance for yourself, a

Short-term and long-term disability

Pre-tax Health Savings Account

Dependent Care

Pet Insurance

Commuter accounts

Employee Perks (tech discount)

Job summary

Diagnostic Group, LLC, part of the Demant Group, is seeking a Quality Assurance Specialist to manage the Quality Management System (QMS) and ensure compliance with FDA, MDR, and MDSAP standards. The role supports multiple brands under the Demant umbrella and leads internal audits, CAPAs, and cross-functional quality initiatives.

Responsibilities include maintaining QMS databases, hosting third‑party audits, training personnel, and coordinating regulatory responses.

Qualifications

• Effective written and verbal communication skills.
• Excellent organizational skills and attention to detail.
• Strong analytical and problem-solving abilities.
• Ability to prioritize tasks in an open office environment.
• Excellent time management and meeting deadlines.
• Proficient with Microsoft Office Suite or related software.

Responsibilities

• Manage the Company’s Quality Management System (QMS) to ensure compliance with FDA 21 CFR Part 820, Regulation (EU) 2017/745 (MDR), MDSAP and other standards, as needed.
• QMS activities for Audioscan and related entities under the Demant umbrella.
• Maintain QMS databases and develop SOPs to improve internal processes.
• Conduct Management Review meetings.
• Facilitate and host 3rd party audits and inspections, coordinate responses to findings, ensure issues are addressed in a timely and compliant manner.
• Plan and execute internal audits to ensure ongoing compliance and continuous improvement within the QMS.
• Plan and execute process CAPAs (Corrective and Preventive Action).
• Ensure relevant personnel are trained in the QMS system, quality policy, and good documentation practice.
• Review and approve quality agreements with suppliers and customers.
• Assist Regulatory Affairs in responding to technical inquiries related to QMS.
• Ensure local changes and improvements comply with global standards.
• All other duties as assigned.

Skills

Effective written and verbal comms

Excellent organizational skills

Analytical and problem-solving

Time management

MS Office proficiency

Education

High school diploma or equivalent

5+ years related experience

ISO 13485/9001 familiarity

ISO 14971 risk management

Job description

Diagnostic Group, LLC, part of the Demant Group, is seeking a Quality Assurance Specialist to manage the Quality Management System (QMS) and ensure compliance with FDA, MDR, and MDSAP standards. The role supports multiple brands under the Demant umbrella and leads internal audits, CAPAs, and cross-functional quality initiatives.

Responsibilities include maintaining QMS databases, hosting third‑party audits, training personnel, and coordinating regulatory responses.