Senior Engineer, QA Engineering (MQ) - Onsite

About the role

Lead and manage Quality Control (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.

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 collaboratively 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.
• Network with contacts outside own area of expertise.
• Work independently, with guidance in only the most complex situations.
• Frequently lead sub-functional teams or projects and train and mentor junior team members.
• Serve as a best practice resource within own area of work.
• Schedule flexibility as needed.

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.

Preferred Qualifications

• Medical device industry experience.
• ASQ certification.
• 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.

Benefits

Employees scheduled to work 30 or more hours per week are eligible for the following benefits package:

• Comprehensive medical, vision, dental, and life insurance.
• AD&D, short-term and long-term disability insurance.
• Sleep care management.
• Health Savings Account (HSA) and Flexible Spending Account (FSA).
• Commuter benefits.
• 401(k) and Employee Stock Purchase Plan (ESPP).
• Employee Assistance Program (EAP).
• Tuition assistance.
• Fifteen days Paid Time Off (PTO) accrued in the first year of employment.
• 11 paid holidays plus 3 floating days.
• 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members.

Pay

A reasonable estimate of the current base range for this position is $122,000 - $184,000. Annual bonus is 5%. Individual pay decisions are based on a variety of factors, such as the candidate’s geographic work location, relevant qualifications, work experience, and skills.