ResMed

Senior Quality Assurance Engineer

Posted 2 Days Ago

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Tebrau, Johor Bahru, Johor, MYS

In-Office

Senior level

Healthtech

The Role

Lead manufacturing quality activities including QMS improvement, new product introductions, risk mitigation, audits, supplier quality, and mentorship to ensure compliance with FDA QSR, GMP, and ISO standards.

Summary Generated by Built In

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).

Let’s talk about Qualifications and Experience

Required

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.

#LI-APAC

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. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.

Skills Required

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
Strong knowledge, application of, and compliance to FDA Quality System Regulations, GMP, and applicable ISO/regulatory standards
Ability to lead and support new product introduction into manufacturing and collaborate with cross-functional teams
Experience performing or supporting internal, external, and supplier audits
Strong interpersonal, communication, negotiation skills and ability to manage stakeholders and work with global teams
Self-starter with strong planning, organizational skills and ability to work with minimal supervision
Experience in Quality and/or Regulatory positions in the medical device industry
Experience developing Quality Agreements, Quality Plans, and Project-Based Risk Assessments
Experience with supplier quality and process validation in a regulated environment

ResMed Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ResMed and has not been reviewed or approved by ResMed.

Strong & Reliable Incentives — Bonuses are considered a meaningful component of total compensation and are paid regularly. Annual payouts and performance incentives are frequently highlighted alongside base pay.
Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, and vision plans that are viewed favorably. Wellbeing resources and flexibility around care reinforce the overall strength of the offering.
Equity Value & Accessibility — An employee stock purchase plan is broadly available and regarded as a valuable ownership benefit. Equity elements are positioned as accessible parts of total rewards across many roles.