Quality Systems Manager

Bisco•Schaumburg, IL

13d•Onsite

About The Position

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.

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.

Nice To Haves

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.

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.