Manage and maintain the Quality Management System for ISO 13485 and medical device regulatory compliance. Oversee QA/QC activities, CAPA, complaints, internal audits, receiving inspection, and QC lab operations. Lead and coach direct and indirect reports, support eQMS use, perform quality data and trend analysis, drive corrective actions, support validation and audit readiness, and partner cross-functionally to resolve quality issues and support continuous improvement.
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.
- 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.
- 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.
- 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.
Please submit your resume for consideration.
A cover letter is optional, but we welcome one to provide additional context on your experience or approach to your work.
Why BISCO, INC.?
Bisco, Inc. stands out because of our culture and core values:
- Respectful – Professional. Humble. Considerate.
- Positive – Friendly. Inclusive. Curious.
- Team Player – Helpful. Cooperative. Flexible.
- Agility of a small company but the stability of a big company
- Industry-leading dental restorative products
- Broad exposure to activities across the company
- Family-oriented environment with positive team players
- Approachable, respectful, and down-to-earth people
- Long-tenured employees to whom the leadership is committed
- Employees feel valued and are proud to be a part of the company
- Monthly whole-company fun events!
Hours: 8:00 a.m. to 4:30 p.m., Monday-Friday
EOE
No agencies please.
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