Senior Quality Assurance Engineer - Lead Data-Driven QA & Compliance

Worklane GmbH; Tebrau; On-site; MYR 60,000 - 90,000; Full time

Job summary

ResMed is seeking a Manufacturing Quality professional to design, implement and monitor quality control programs ensuring products meet specifications and regulatory standards. You will lead quality initiatives, perform audits, and collaborate across QA, design, supplier, and manufacturing teams globally.

Responsibilities include supporting KPI delivery, leading new product introductions, improving QMS across sites, and applying risk-based decisions with data analytics to drive quality and

Qualifications

• Bachelor’s degree in Engineering or Science; 5 years in a regulated volume manufacturing industry.
• Experience in Quality Systems / Manufacturing quality, risk management, requirements management and process validation.
• Self-starter, with the ability to work with minimal supervision and with a sense of urgency.
• Good planning and organisational skills; ability to take own initiative and ownership.
• Strong inter-personal, communication, and negotiation skills with the ability to interact positively with senior management and manage stakeholders.
• Ability to work effectively with global teams, maintaining good relationships while influencing change.

Responsibilities

• Support the Factory Focus teams to achieve KPI of Quality, Delivery and Cost.
• Lead and support new products introduction process into manufacturing with cross-functional collaboration.
• Pro-actively improve quality systems to support manufacturing across QA and production.
• Ensure risk of non-compliance and related business risks are mitigated.
• Provide quality / technical leadership through mentoring/coaching.
• Ensure compliance to FDA QSR/ GMP and ISO/regulatory standards.
• Collaborate with QA functions across ResMed (Quality systems, Audit, design, supplier, manufacturing, customer quality).
• May perform Quality representative role for Operations projects (site moves, new processes).
• Develop Quality Agreements, Quality Plans, Risk Assessments.
• Perform or support internal / external / supplier audits.
• Partner with stakeholders to apply risk-based decision making for outcomes.
• Support/remote leadership in Quality Engineering across global team.
• Utilize data analytics, machine learning insights, and statistics for root cause, CAPA, and decisions.
• Drive continuous improvement via automation, predictive quality monitoring, and QMS optimization.

Skills

Quality systems

Manufacturing quality

Risk management

Process validation

Stakeholder management

Communication

Global teamwork

Planning & organisation

Self-starter

Education

Bachelor’s degree in Engineering or Science

Job description

ResMed is seeking a Manufacturing Quality professional to design, implement and monitor quality control programs ensuring products meet specifications and regulatory standards. You will lead quality initiatives, perform audits, and collaborate across QA, design, supplier, and manufacturing teams globally.

Responsibilities include supporting KPI delivery, leading new product introductions, improving QMS across sites, and applying risk-based decisions with data analytics to drive quality and