Quality Engineering ManagerWe are seeking an experienced
Quality Engineering Manager for our
Aurora, Colorado facility to lead Quality Engineering activities and ensure manufacturing processes, laboratory systems, equipment, utilities, cleaning processes, and computerized systems remain qualified and validated throughout their lifecycle. This role drives validation programs, quality risk management, change control, and continuous improvement initiatives that support compliance, product quality, operational excellence, and business growth.
Annual Salary Range: $115,000-$140,000
Key Responsibilities:Quality, Compliance & Safety
- Ensure compliance with GMP, EHS, sustainability, company standards, and regulatory requirements.
- Maintain audit and inspection readiness; support internal, customer, and regulatory audits.
- Promote a culture of quality, compliance, accountability, and risk management.
Validation & Qualification
- Develop validation strategies, governance processes, and the Site Validation Master Plan.
- Lead qualification and validation of manufacturing processes, equipment, utilities, cleaning processes, laboratory systems, and computerized systems.
- Review and approve validation protocols, reports, risk assessments, and related documentation.
- Serve as site validation SME, providing training and technical guidance.
Quality Systems & Continuous Improvement
- Oversee product specifications and Master Batch Record (MBR) governance, ensuring compliance and effective change implementation.
- Lead investigations involving complaints, deviations, nonconformances, and quality events; drive effective CAPAs.
- Establish and monitor KPIs supporting validation, compliance, quality systems, and change management.
- Drive continuous improvement initiatives that enhance compliance, product quality, and operational performance.
Leadership & Collaboration
- Lead and develop a high-performing Quality Engineering team.
- Promote collaboration, accountability, and continuous improvement.
- Partner cross-functionally to support strategic initiatives, business projects, and new product introductions.
Qualifications:- Bachelor's degree in Engineering, Chemistry, Biological Sciences, Manufacturing, Quality, or related technical field required; Master's preferred.
- 7+ years of experience in Quality, Engineering, Validation, Manufacturing, or another regulated industry.
- Demonstrated leadership experience managing teams and cross-functional initiatives.
- Strong knowledge of GMP, quality systems, validation methodologies, and Quality Risk Management.
- Experience with CSV, data integrity, electronic quality systems, and knowledge of 21 CFR Part 11 preferred.
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