Quality Associate III (Medtech)

Location: Round Lake, Illinois, United States. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available.

Salary: $96,000–$132,000 annually, with potential discretionary bonuses.

Company

Healthcare company developing and manufacturing products intended to save and sustain lives.

What you will do

• Own or provide senior-level oversight for QMS processes including change control, CAPA, complaints, nonconformances, metrics, and management review.
• Serve as a site subject matter expert, coordinating workflow routing, impact assessment, implementation, closure quality, and inspection readiness in eQMS platforms.
• Lead complex quality investigations, root cause analysis, corrective and preventive actions, and effectiveness verification.
• Assess changes affecting products, processes, equipment, suppliers, documentation, quality systems, regulatory compliance, patient safety, and data integrity.
• Prepare dashboards, trend reports, management review packages, and executive summaries covering QMS performance and risks.
• Support audits and regulatory inspections, lead continuous improvement initiatives, and train process users and cross-functional quality stakeholders.

Requirements

• Bachelor’s degree in science, engineering, pharmacy, life sciences, quality, regulatory affairs, or a related technical discipline.
• At least 4 years of experience in quality assurance, quality systems, quality engineering, manufacturing quality, product surveillance, or compliance within a regulated pharma, biotech, or medical device environment.
• Hands-on experience with at least two QMS elements, such as CAPA, change control, complaints, nonconformance, deviations, audits, management review, metrics, or document control.
• Experience supporting FDA, ISO, notified body, corporate, customer, or health authority inspections.
• Experience with eQMS and quality reporting tools such as TrackWise, Veeva, MasterControl, ETQ, SmartSheet, Power BI, Excel, Tableau, TcU, or SAP.
• Working knowledge of FDA 21 CFR, ISO 13485, EU MDR, ICH, cGMP, QSR, or comparable global QMS requirements.

Nice to have

• ASQ certification, Six Sigma Green Belt or Black Belt, RAC, or an equivalent quality or process-improvement credential.
• Experience with sterile drug products, combination products, device-drug products, biologics, or high-volume regulated manufacturing.
• Experience simplifying QMS processes while maintaining compliance, traceability, data integrity, and inspection readiness.

Culture & Benefits

• Collaborative quality environment combining independent ownership with cross-functional teamwork.
• Medical and dental coverage beginning on the first day, plus life, accident, and disability insurance.
• 401(k) retirement savings plan with company matching and an employee stock purchase plan.
• Paid holidays, 20–35 days of paid time off based on service length, family and medical leave, and paid parental leave.
• Educational assistance, commuting benefits, childcare benefits, employee assistance, and employee discounts.