Senior Engineer, QA Engineering (MQ) - Onsite

ResMed • Calabasas, CA

2d • $122,000 - $184,000 • Onsite

About The Position

The Senior Engineer, Quality Engineering (Manufacturing Quality) is responsible for leading QC operations while providing Quality Engineering support for manufacturing. The role ensures product quality, regulatory compliance, effective quality systems, and continuous improvement through leadership of quality inspections, investigations, NPI activities, manufacturing quality initiatives, and cross-functional collaboration.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Lead and manage Quality Control (QC) teams to ensure inspection activities support production schedules, product quality, and business objectives.
• Support Factory Focus Teams in achieving Quality, Delivery, and Cost (QDC) KPIs.
• Provide day-to-day leadership, coaching, mentoring, and development of personnel.
• Drive quality oversight for manufacturing operations, including inspection, nonconforming material disposition, root cause investigations, CAPAs, and continuous improvement initiatives.
• Lead and support New Product Introduction (NPI) activities, ensuring quality deliverables, risk management, and successful transfer into manufacturing.
• Partner and work collaborative with Manufacturing, Engineering, Supply Chain, Supplier Quality, and Operations teams to resolve quality issues and improve process performance.
• Monitor and analyze quality metrics and inspection data to identify trends, improve efficiency, and drive corrective and preventive actions.
• Ensure compliance with ResMed Quality Management System (QMS), FDA Quality System Regulations, GMP, ISO standards, and applicable regulatory requirements.
• Maintain and improve manufacturing quality systems, inspection processes, risk assessments, validation activities, and quality plans.
• Support internal, external audits, and ensure timely closure of audit observations.
• Serve as a quality representative for strategic operational initiatives including site expansions, process changes, equipment transfers, and business integration activities.
• Promote a culture of quality, accountability, compliance, and continuous improvement across manufacturing and quality functions.
• Networks with contacts outside own area of expertise.
• Works independently, with guidance in only the most complex situations.
• Frequently leads sub-functional teams or projects and train and mentor junior team members.
• Serves as a best practice resource within own area of work.
• Schedule flexibility as needed

Benefits

• comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance.
• Employees accrue fifteen days Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.

What This Job Offers

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