Quality Assurance Specialist

Overview

Diagnostic Group, LLC is part of the Demant Group. Demant is a world-leading hearing healthcare group that for more than a century has played a vital part in developing innovative technologies and knowledge to help improve people’s hearing and health. In every aspect, from hearing devices, hearing implants and diagnostic equipment to intelligent 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.

Compensation: $90K+ salary and up depending on experience. 

Office Location: Eden Prairie MN-incubmbent must live within a reasonable distance of our office as this position requires the incumbent to work onsite fully initially and then a minimum of 3 days per week after successful completion of training.

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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