Quality Engineer, QA Engineering (MQ)

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Johor Bahru, Johor
Internship
Healthtech
The Role

Job Description Summary:

To support/improve production quality and GMP compliance to meet Quality, Delivery and Cost through the development and application of quality systems in production.

Let’s talk about Responsibilities

• Support the Factory Focus teams to achieve the deliverables for current KPI of Quality, Delivery and Cost.

• Assist to 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.

• Assist in risk of non-compliance and related business risks are mitigated.

• Support/remote support technical leadership in Quality Engineering across global team. 

• Build positive working relationships with internal and external customers to ensure QA purpose and vision is recognized as integral to business success and growth.

• Foster quality culture through involvement in ongoing education, consultation in the Quality/Regulatory requirements

• Ensure compliance to ResMed QMS and overall compliance to applicable regulatory standards.

Let’s talk about Qualifications:

• Tertiary Qualification in Engineering or Science

  • Excellent English written and verbal communication skills, with the ability to communicate technical information clearly and effectively.
  • Strong attention to detail and accuracy, with the ability to review and interpret technical documentation.
  • Ability to work independently and collaboratively in a fast-paced environment with changing priorities.

Preferred

· Knowledge of quality management systems, regulatory requirements (e.g., ISO 13485, FDA regulations), and medical device standards (e.g., ISO 14971, IEC 60601).

· Previous experience in a quality assurance role in the medical device or pharmaceutical industry.

· Strong analytical and problem-solving skills, with the ability to identify issues, analyze data, and implement effective solutions.

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!

The Company
HQ: San Diego, CA
5,300 Employees
On-site Workplace
Year Founded: 1989

What We Do

ResMed provides medical equipment for treating, diagnosing, and managing sleep-disordered breathing and other respiratory disorders.

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