Quality Systems Manager

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

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 of the Quality Systems Manager:
The job responsibilities of this position may include, but are not limited to:

• 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 escalate 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…