Quality Manager

Medical Murray • Lake Zurich, IL

36d • Onsite

About The Position

We are looking for a Quality Manager who is passionate about quality, compliance, and continuous improvement to join our team. In this role, you will lead the site Quality team and help ensure our products consistently meet customer expectations and regulatory standards.

This is an exciting opportunity for a hands-on quality professional who enjoys working cross-functionally, leading teams, and driving improvements in a highly regulated environment. The ideal candidate brings strong technical knowledge, leadership skills, and a commitment to building a culture of quality across the organization.

Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline.
• 3–5 years of experience in Quality Engineering, ideally within the medical device industry.
• Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820 cGMP regulations.
• Previous team leadership or supervisory experience.
• Experience supporting quality systems, audits, and regulatory compliance activities.
• Strong analytical and problem-solving abilities with high attention to detail.
• Excellent organizational and prioritization skills in a fast-paced environment.
• Effective communication and collaboration skills across teams and functions.
• Proficiency with Microsoft Office Suite.
• A proactive, hands-on approach and a strong commitment to maintaining the highest quality standards.

Nice To Haves

• ASQ or similar professional certification is a plus.
• Knowledge of microbiology and sterilization processes is preferred.

Responsibilities

• Lead and support the local Quality Control team, ensuring products meet specifications and customer quality requirements.
• Champion compliance with the Quality Management System, including applicable SOPs and training requirements.
• Ensure inspection activities are properly staffed and equipped to support production schedules and delivery objectives.
• Recruit, develop, and mentor quality team members while conducting performance reviews and supporting professional growth.
• Ensure inspections and documentation are completed accurately and efficiently, maintaining current work instructions and quality forms.
• Review in-process inspection reports and ensure timely processing and disposition of materials.
• Maintain and monitor site quality metrics, identify trends, and share insights with leadership to support continuous improvement.
• Review and approve Lot History Records and support sterilization shipment documentation as required.
• Partner with operations and engineering teams on process validation, verification activities, and process improvements.
• Participate in risk management activities, design reviews, and process transfer initiatives.
• Support product and process transfer activities including Process FMEA, documentation review, vendor approvals, capability evaluation, and statistical analysis.
• Review and investigate customer complaints and failure analysis when needed.
• Lead the Material Review Board (MRB) process for nonconforming materials.
• Represent the organization during external audits, including FDA, Notified Body, and customer audits.
• Manage the Approved Vendor List (AVL) and support vendor performance reviews.
• Support site equipment coordination responsibilities in accordance with company procedures.

Benefits

• We offer a competitive compensation and benefits package, including medical (BCBS) and dental coverage, company-paid vision and life insurance, short- and long-term disability, HSA-eligible plans, a 401(k) Safe Harbor retirement plan, 18 days of PTO, TeleDoc access, identity protection, tuition reimbursement, voluntary life insurance, and paid time off for community volunteering.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager