Quality Systems Manager

biscodentalproducts; Schaumburg (IL); On-site; USD 110,000 - 129,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

HRA and FSA

Short and long-term disability

Life insurance

PTO

401(k) profit-sharing with match

Potential year-end bonuses

Job summary

BISCO is seeking a Quality Systems Manager to lead and maintain the Quality Management System in Schaumburg, IL, ensuring ISO 13485 compliance and regulatory readiness. This hands-on leadership role oversees QA/QC activities, receiving inspection, CAPAs, internal audits, data analysis, and cross-functional collaboration with Regulatory Affairs, R&D, Manufacturing, and Operations.

The ideal candidate will coach teams, drive continuous improvement, and balance compliance with practical business

Qualifications

• Bachelor's degree required; prefer Chemistry, Biology, Engineering or related science.
• 8+ years in quality systems, QA/QC, or medical device quality functions.
• Knowledge of ISO 13485:2016, FDA QSR, and MDSAP is preferred.
• Experience with CAPA, nonconformities, complaints, document control, and audits.
• Proven leadership, coaching, and cross-functional collaboration.
• Excellent written and verbal communication for procedures and quality requirements.
• Proficiency in Microsoft Office (Excel, Word, Outlook, Teams).

Responsibilities

• Maintain and improve Quality Management System per ISO 13485 and regulatory requirements.
• Oversee QA processes: nonconformities, complaints, CAPAs, internal audits.
• Lead QC laboratory and receiving inspection activities.
• Coach and develop direct and indirect reports.
• Manage use of QMS software and support improvements.
• Prepare management review reports using quality data.
• Support validation activities for software, processes, equipment, and tests.
• Collaborate with cross-functional teams to resolve quality issues.
• Support audit readiness and corrective actions.
• Assist with resource planning, budgets, and continuous improvement.

Skills

Quality leadership

QA/QC processes

Regulatory compliance

CAPA

Internal audits

Data analysis

Communication

Mentorship

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Tools

eQMS software

NetSuite

MS Office

Job description

This position is based out of our office in Schaumburg, IL.

Quality Systems Manager

BISCO is seeking a Quality Systems Manager to manage and maintain BISCO’s Quality Management System and oversee key QA/QC activities in support of ISO 13485 and applicable medical device regulatory requirements.

This is a hands‑on management role with responsibility for quality system processes, QA functions, QC laboratory activities, receiving inspection, audit readiness, and quality data analysis. The role works closely with Quality, Regulatory Affairs, R&D, Manufacturing, Operations, and external partners to resolve quality issues and support continued compliance.

The ideal candidate is a practical quality leader who can manage and coach direct and indirect reports, maintain quality system discipline, analyze data and trends, and drive timely follow‑through on quality issues. This role requires strong judgment, clear communication, and the ability to balance compliance expectations with collaborative, business‑practical problem solving.

Salary range: $110k to $129k, commensurate with experience

Benefits: Medical, dental, and vision insurance, HRA and FSA, short and long‑term disability, life insurance, pet insurance, PTO, 401(k) profit‑sharing with match, potential year‑end bonuses.

RESPONSIBILITIES

• Manage, maintain, and improve BISCO’s Quality Management System in accordance with ISO 13485 and applicable regulatory requirements.
• Manage key QA processes, including nonconformity reports, complaints, CAPAs, internal audits, and related follow‑up activities.
• Oversee QC laboratory and receiving inspection activities, including raw material inspection, work‑in‑process inspection, stability monitoring, equipment, and related product trend analysis.
• Lead, coach, and develop direct and indirect reports, including training, performance management, accountability, and routine team communication.
• Manage effective use of BISCO’s QMS software and support eQMS‑related improvements.
• Support quality data and trend analysis and prepare reports for Management Review.
• Support software, process, equipment, and test method validation activities.
• Partner with cross‑functional process owners, managers, directors, and external business partners to resolve quality issues in a timely manner.
• Support audit readiness, audit responses, and corrective actions related to quality system processes.
• Support resource planning, budgets, capital projects, and continuous improvement activities for responsible areas.

ROLE EXPECTATIONS

• Lead, manage, and hold direct and indirect reports accountable with clear expectations and consistent follow‑up.
• Maintain Quality System discipline while helping teams understand and meet compliance requirements.
• Use quality data, trend analysis, and audit results to identify risks and drive practical corrective actions.
• Partner across departments with process owners, managers, directors, and business partners to resolve quality issues.
• Exercise independent judgment and know when to elevate matters that affect compliance, resources, or product quality.
• Coach and develop staff through feedback, training, and work assignments.
• Foster a collaborative, continuous‑improvement mindset within Quality and across cross‑functional teams.

REQUIREMENTS

• Bachelor's degree required; degree in Chemistry, Biology, Engineering, or related science preferred; Quality certification, such as ASQ, preferred.
• 8+ years of experience in quality systems, quality assurance, quality control, or related medical device quality functions.
• Working knowledge of ISO 13485:2016, FDA Quality System requirements, and MDSAP experience 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 skills, including the ability to author and validate test methods, procedures and communicate quality requirements to stakeholders.
• Strong problem‑solving skills, including root cause analysis and corrective action effectiveness.
• Proficiency with Microsoft Office, especially Excel, Word, Outlook, and Teams.

PREFERRED QUALIFICATIONS

• Prior supervisory or team lead experience.
• Experience in a medical device, pharmaceutical, or regulated manufacturing environment.
• Internal audit experience.
• Experience with eQMS software; NetSuite experience a plus.
• Familiarity with GLP, lab safety, good documentation practices, validation, receiving inspection, or QC laboratory operations.
• ASQ certification or similar quality certification.

Hours: 8:00 a.m. to 4:30 p.m., Monday-Friday

EOE