Manager, Quality Engineering (Medtech)

Location: Round Lake, Illinois, United States

Salary: $112,000–$154,000 annually, plus potential discretionary bonuses.

Company

Healthcare company focused on developing solutions that help save and sustain lives.

What you will do

• Lead the Quality Engineering function and provide independent QA oversight of site validation and plant-level data integrity programs.
• Establish governance models, procedures, decision rights, risk tolerances, and performance expectations.
• Lead, develop, and performance-manage the Quality Engineering team while assigning oversight according to project risk and priority.
• Approve or delegate approval of validation plans, high-risk protocols and reports, critical deviations, revalidation strategies, and major change controls.
• Chair governance forums, resolve cross-functional ownership and resource conflicts, and escalate program risks to site leadership.
• Represent validation and data integrity programs during FDA inspections, customer audits, governance reviews, and regulatory submissions.

Requirements

• Expert knowledge of cGMP validation, computerized-system assurance, GAMP 5, 21 CFR Part 11, ALCOA+ principles, data integrity governance, and quality systems.
• Bachelor’s degree in Engineering, Science, Computer Science, or a related technical discipline.
• 8 or more years of progressive experience in validation, quality engineering, computerized-system assurance, data integrity, or QA within a cGMP-regulated industry, including people or program leadership.
• Strong strategic planning, risk-based decision-making, governance, influencing, negotiation, conflict-resolution, and communication skills.
• Experience leading complex programs, inspections, remediation governance, and cross-functional organizational change.
• Must be authorized to work for any employer in the United States; visa sponsorship is not available.

Nice to have

• Experience participating in regulatory inspections and complex remediation programs.
• ASQ CQE, CSQE, CQA, Six Sigma, or comparable professional certification.

Culture & Benefits

• Mission-driven environment focused on saving and sustaining lives.
• Collaborative culture emphasizing courage, trust, ownership, and accountability.
• Medical and dental coverage beginning on the first day for eligible employees.
• 401(k) retirement plan with employee contributions and company matching, employee stock purchase plan, and flexible spending accounts.
• Paid holidays, paid time off, family and medical leave, and paid parental leave.
• Educational assistance, commuting benefits, employee discount program, employee assistance program, and childcare benefits.