Quality Assurance Specialist

4 days ago


Johor Bahru, Johor, Malaysia ResMed Inc Full time
Quality Assurance Specialist, Quality Systems Engineering

Job Summary:

We are seeking a highly skilled Quality Assurance Specialist to support the development and application of quality systems in production, ensuring compliance to ResMed QMS and regulatory standards.

Key Responsibilities:

  1. Collaborate with Factory Focus teams to achieve quality, delivery, and cost objectives.
  2. Conduct reviews across manufacturing and QA production support teams to ensure consistency and standardization in ResMed QMS.
  3. Identify and mitigate risks of non-compliance and related business risks.
  4. Provide technical leadership in Quality Engineering across the global team.
  5. Develop positive working relationships with internal and external customers to promote QA's purpose and vision.
  6. Foster a quality culture through education and consultation on Quality/Regulatory requirements.
  7. Ensure compliance to ResMed QMS and regulatory standards.

Requirements:

  • Tertiary qualification in Engineering or Science.
  • Excellent English written and verbal communication skills.
  • Strong attention to detail and accuracy.
  • Ability to work independently and collaboratively in a fast-paced environment.

Preferred Qualifications:

  • Knowledge of quality management systems, regulatory requirements, and medical device standards.
  • Previous experience in a quality assurance role in the medical device or pharmaceutical industry.
  • Strong analytical and problem-solving skills.

We are a company driven by excellence, where a culture of diversity and inclusion encourages individual expression and innovative ideas. If you are a motivated professional looking for a challenging and supportive work environment, apply now.



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