Senior Engineer, QA Engineering (MQ) - Onsite
$122,000–$184,000 year
On-siteCalabasas, California, United States
Job Summary
Lead and manage Quality Control teams to ensure inspection activities support production schedules, product quality, and business objectives. Drive quality oversight for manufacturing operations, including inspection, nonconforming material disposition, root cause investigations, CAPAs, and continuous improvement initiatives. Support Factory Focus Teams in achieving Quality, Delivery, and Cost KPIs while leading New Product Introduction activities and ensuring successful transfer into manufacturing. Partner with Manufacturing, Engineering, Supply Chain, and Operations teams to resolve quality issues and improve process performance. Monitor quality metrics, analyze inspection data, and ensure compliance with ResMed Quality Management System, FDA regulations, GMP, and ISO standards. Maintain quality systems, inspection processes, and risk assessments while supporting internal and external audits. Serve as a quality representative for strategic initiatives including site expansions and equipment transfers. Provide day-to-day leadership, coaching, and mentoring to junior team members.
Required Qualifications
- Bachelor's degree in Engineering, Science, or related field
- 5+ years of experience in Manufacturing Quality, Quality Engineering, or Quality Control within a regulated manufacturing environment
- Experience with Quality Systems, risk management, process validation, CAPA, nonconformance management, and root cause investigations
- Demonstrated leadership experience managing, mentoring, or supervising QC and/or quality personnel
- Strong collaboration, communication, stakeholder management, and problem-solving skills
- Working knowledge of FDA QSR, GMP, ISO 13485, MDSAP and applicable regulatory requirements
- Schedule flexibility as needed
Desired Qualifications
- Medical device industry experience
- ASQ certified
- Knowledge of Lean Manufacturing, Six Sigma, and continuous improvement methodologies
- Experience utilizing data analytics AI-enabled tools to improve quality performance and operational decision-making
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