Senior Quality Assurance Engineer

Resmed; Tebrau; On-site; MYR 120,000 - 180,000; Full time

Job summary

ResMed in Malaysia seeks a Manufacturing Quality professional to design, implement and monitor quality control programs ensuring products meet specifications and regulatory requirements.

You will lead quality systems improvements across manufacturing units, drive risk-based decision making, and mentor QA teams while collaborating with global partners to optimize processes using analytics and AI-enabled tools.

Qualifications

• Bachelor’s degree in Engineering or Science.
• 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 product introductions with QA cross-function involvement.
• Improve quality systems to standardize ResMed QMS across sites.
• Ensure compliance to QMS with FDA, GMP, and ISO standards.
• Provide quality leadership through mentoring and coaching of teams.
• Perform audits and partner with stakeholders on risk-based decisions.

Skills

Quality systems

Process validation

Risk management

Data analytics

Education

Bachelor's degree in Engineering or Science

Job description

The primary role of Manufacturing Quality function is to design, implement and monitoring quality control programs. Key deliverables include, but not limited to, recommending changes to methods, procedures and standards to improve quality of output based on analysis of data and systems. Ensures products are built correctly to specification, quality standards and appropriate regulatory compliance. Reports defects and tracks until resolution.

Let’s Talk About Responsibilities

• Support the Factory Focus teams to achieve current KPI of Quality, Delivery and Cost
• Lead and support new products introduction process into manufacturing with active involvement in appropriate XFT deliverables and phase transitions in collaboration with QA counterpart in XFT and QA/RA team
• Pro-actively improve quality systems to support manufacturing including reviews across all areas of manufacturing and QA production support team to ensure a level of consistency and standardization in ResMed QMS across various manufacturing business units and sites
• Ensure risk of non-compliance and related business risks are mitigated
• Provide quality / technical leadership through mentoring/coaching
• Ensure compliance to ResMed QMS; strong knowledge, application of and compliance to FDA Quality System Regulations, GMP, and applicable ISO / regulatory standards
• Ability to work collaborative across various QA functions in ResMed (Quality systems & Audit, design, supplier, manufacturing, and customer quality)
• May perform Quality representative role for Operations projects and business activities that require broad quality expertise and support, eg: site moves / expansions, new process / business ventures, support / integration of acquired companies.
• Develop Quality Agreements, Quality Plans, Project Based Risk Assessment
• Perform or support internal / external / supplier audits
• Partner with stakeholders and other functions to understand business & quality requirements and apply appropriate risk-based decision making to achieve successful business and customer outcomes
• Support/remote support technical leadership in Quality Engineering across global team.
• Utilize advanced data analytics, machine learning insights, and statistical methodologies to support root cause investigations, CAPA effectiveness reviews, and risk-based decision making.
• Ensure AI-enabled quality systems and automated decision-support tools comply with applicable regulatory requirements, quality standards, data governance policies, and validation expectations.
• Drive continuous improvement initiatives by identifying opportunities for automation, predictive quality monitoring, and intelligent process optimization within the Quality Management System (QMS).

Required

Let’s talk about Qualifications and Experience

• Bachelor’s degree in Engineering or Science with 5 years’ experience 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.

Preferred

• Experience in Quality and/or Regulatory positions in medical device industry.
• Experience in Quality System, Manufacturing Quality, process validation and risk manage.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.