QA & Compliance Specialist, Medical Devices & QMS

Hearing Screening Associates; Eden Prairie (MN); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) with company match

Life insurance

Disability insurance

HSA/FSA for Health Care

Dependent care

Pet Insurance

Commuter accounts

Tech discount

Job summary

Diagnostic Group, LLC, part of the Demant Group, is seeking a Quality Assurance Specialist to support the QMS and ensure compliance with FDA and international standards. You will contribute to continuous improvement across multiple brands, including Audioscan and Grason‑Stadler.

The role requires experience with ISO 13485/9001 and ISO 14971, strong documentation skills, and the ability to coordinate audits and CAPAs with cross‑functional teams. Minnesota-based position with travel.

Qualifications

• Strong written and verbal communication skills.
• Excellent organizational skills and attention to detail.
• Analytical and problem-solving abilities with strong data-driven mindset.
• Ability to prioritize tasks in a fast-paced environment.
• Excellent time management and meeting deadlines.
• Proficiency with Microsoft Office Suite and related software.

Responsibilities

• Manage the Company’s Quality Management System (QMS) to ensure FDA 21 CFR Part 820, MDR, MDSAP compliance.
• Oversee QMS activities for Audioscan, MedRx, and Diagnostic Group brands.
• Maintain QMS databases and develop SOPs to improve processes.
• Conduct Management Review meetings and host 3rd party audits.
• Plan and execute internal audits and CAPAs.
• Train personnel on QMS, quality policy, and documentation practices.
• Review and approve supplier/customer quality agreements.
• Assist Regulatory Affairs with technical inquiries related to QMS.

Skills

Written & verbal comms

Organization

Analytical skills

Task prioritization

Time management

MS Office

Education

High school diploma

5+ years QA experience

ISO 13485/9001

ISO 14971 risk management

Quality tools & methodologies

Tools

None

Job description

Diagnostic Group, LLC, part of the Demant Group, is seeking a Quality Assurance Specialist to support the QMS and ensure compliance with FDA and international standards. You will contribute to continuous improvement across multiple brands, including Audioscan and Grason‑Stadler.

The role requires experience with ISO 13485/9001 and ISO 14971, strong documentation skills, and the ability to coordinate audits and CAPAs with cross‑functional teams. Minnesota-based position with travel.