Quality Systems Leader - Medical Devices (ISO 13485)

BISCO Dental Products; Schaumburg (IL); On-site; USD 110,000 - 129,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

HRA and FSA

Disability insurance

Life insurance

PTO

401(k) with match

Year-end bonuses

Job summary

BISCO Dental Products seeks a Quality Systems Manager to maintain the Quality Management System and oversee QA/QC activities in support of ISO 13485 and medical device regulatory requirements.

This hands-on leadership role involves managing quality system processes, QA/QC activities, and laboratory operations, while coaching teams, analyzing data, and ensuring timely corrective actions to sustain compliance.

Qualifications

• Bachelor's degree in a related science; ASQ certification preferred.
• 8+ years of experience in quality systems, QA, QC, or related medical device quality functions.
• Working knowledge of ISO 13485:2016, FDA QSR, and MDSAP preferred.
• Experience with CAPA, nonconformities, complaints, document control, internal audits, or similar QMS processes.
• Ability to lead people, set expectations, coach team members, and follow through on commitments.
• Strong written and verbal communication to validate test methods and quality requirements.

Responsibilities

• Manage, maintain, and improve the Quality Management System per ISO 13485 and regulatory requirements.
• Oversee QA processes, including nonconformities, complaints, CAPAs, audits, and follow-ups.
• Supervise QC lab and receiving inspection, with trend analysis and material testing oversight.
• Lead and develop direct and indirect reports; provide coaching and performance management.
• Manage use of the QMS software and support improvements to eQMS.
• Support quality data analysis and Management Review reporting.
• Coordinate with cross-functional process owners to resolve quality issues in a timely manner.
• Support audit readiness, responses, and corrective actions.

Skills

Quality leadership

Data analysis

Regulatory knowledge

CAPA management

Root cause analysis

Documentation control

Communication skills

Team leadership

Education

Bachelor's degree in science

ASQ certification

Tools

eQMS software

NetSuite

Microsoft Office

Job description

BISCO Dental Products seeks a Quality Systems Manager to maintain the Quality Management System and oversee QA/QC activities in support of ISO 13485 and medical device regulatory requirements.

This hands-on leadership role involves managing quality system processes, QA/QC activities, and laboratory operations, while coaching teams, analyzing data, and ensuring timely corrective actions to sustain compliance.