Quality Assurance Specialist

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 is part of the Demant Group. Demant is a world-leading hearing healthcare group thatfor more than a century has played a vital part in developinginnovative technologies and knowledge to help improvepeople’s hearing and health. In every aspect, from hearingdevices, hearing implants and diagnostic equipment tointelligent audio solutions and hearing care all over the world, Demant is active and engaged.

The Demant group covers five business areas: Hearing Care, Hearing Aids, Hearing Implants, Diagnostics, and Communications.

The Quality Assurance Specialist plays a key role in supporting the company’s Quality Management System and helping ensure organizational compliance with applicable quality and regulatory standards. This position contributes to quality‑related activities, continuous improvement efforts, and cross‑functional collaboration to maintain high levels of product and process integrity.

Full-time benefits include:

• Medical, dental, prescription, and vision benefits
• 24/7 virtual medical care
• Employee Assistance Program for you and your family
• 401(k) with company match
• Company-paid life insurance
• Supplemental insurance for yourself, your spouse/partner, and your children
• Short-term and long-term disability insurance
• Pre-tax Health Savings Account and Flexible Spending Accounts for Health Care or
• Dependent Care
• Pet Insurance
• Commuter accounts
• Employee Perks (tech discount)

Responsibilities

• Responsible for managing 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.
• Responsible for QMS activities for the following:
  • Etymonic Design Inc. operating as Audioscan
  • MedRx, Inc.
  • Diagnostic Group LLC dba (1) Amplivox (2) Grason-Stadler (3) Interacoustics US (4) Maico-Diagnostics (5) Tremetrics
  • E3 Diagnostics Inc.
  • Hearing Screening Associates (HSA)
• 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 the findings, and ensure all issues are addressed in a timely and compliant manner.
• Plan and execute internal audits to ensure ongoing compliance and continuous improvement within the Quality Management System.
• 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.

Qualifications

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

Education and Experience

• High school diploma or equivalent.
• At least 5 years’ related experience preferred.
• Experience with ISO 13485/9001 quality system environments.
• Experience with Risk management/ISO 14971.
• Previous Quality experience and demonstrated use of Quality tools/methodologies.

Travel

• Must be able to travel internationally and domestically for up to 15 days per year.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Physically able to reach, stretch, bend, and sit for extended periods of time during a daily routine.
• Must be able to lift up to 25 pounds at times.

Pre‑Employment Requirements

• Clear background check including criminal history and education verification.

Diagnostic Group, LLC is an Equal Opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, sex, national origin, disability, or protected veteran status.

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