Quality Assurance Specialist - InMarket Quality

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 know-how 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. 

Diagnostic Group, LLC is looking for an experienced Quality Assurance Specialist - InMarket Quality to join our team in Arlington Heights, IL. The Quality Assurance Specialist, InMarket Quality supports the ongoing safety and performance of diagnostic products by managing complaints, customer feedback, and post‑market surveillance activities. This role collaborates with cross‑functional teams to ensure timely communication, regulatory‑aligned documentation, and thorough follow‑up on CAPA, risk management, and vigilance. This is a hybrid role. 

Compensation: $70k-$75k/yr

• Capture, assess, and communicate customer complaints and feedback across the Diagnostics organization, ensuring issues are documented accurately and shared with the appropriate stakeholders.
• Participate in complaint review board (CRB) meetings in coordination with Product Management, ensuring actions are being tracked, documented, and followed through to completion.
• Manage Product CAPA process, including root cause analysis, ensuring information from complaints and customer feedback are addressed and improvements are communicated to key stakeholders.
• Serve as the North America point of contact for adverse events and vigilance topics, ensuring timely communication to the appropriate stakeholders in accordance with regulatory guidelines.
• Prepare and update required documentation such as Post-Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR).
• Collaborate with cross-functional teams to update risk management files based on post-market findings.
• Recommend design or process improvements based on field performance.
• Work closely with Regulatory Affairs, Quality Assurance, Clinical Affairs, and R&D teams.
• Support internal audits and external inspections related to post-market surveillance activities.
• Support the development and improvement of post-market surveillance procedures and tools
• Create quality plans and assist R&D with new product introduction (NPI) planning.
• Review and approve documentation from R&D and product management, including:
  • Risk Management Files
  • Product Requirements Documents
  • Usability Documentation
  • Validation Plans
• All other duties as assigned.

• 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.
• Experience with EU MDR requirements and compliance a plus.

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 long periods of time during a daily routine. 
• Must be able to lift up to 25 pounds at times. 

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