QA Engineer

Job Summary:
The Manufacturing Quality function is responsible for designing, implementing, and monitoring quality control programs. Key responsibilities include recommending improvements to methods, procedures, and standards based on data analysis to enhance product quality. The QA Engineer ensures products are manufactured according to specifications, quality standards, and regulatory compliance. They identify defects and track resolution progress to maintain high-quality output.

Job Description

The QA Engineer will support and improve production quality and Good Manufacturing Practice (GMP) compliance to achieve quality, delivery, and cost objectives. This is accomplished through the development and application of quality systems in manufacturing.

Let’s talk about Responsibilities

• Support Factory Focus teams in meeting KPIs related to Quality, Delivery, and Cost.

• Assist in enhancing quality systems across manufacturing, including cross-functional reviews to ensure consistency and standardization of ResMed’s Quality Management System (QMS) across multiple sites.

• Identify and mitigate risks related to non-compliance and business operations.

• Provide technical leadership and support to Quality Engineering teams globally.

• Build strong working relationships with internal and external stakeholders to promote QA’s role as a critical component of business success.

• Foster a quality-driven culture through ongoing education and consultation on Quality and Regulatory requirements.

• Ensure compliance with ResMed’s QMS and all applicable regulatory standards.

Let’s talk about Qualifications:
Required:

• Bachelor’s degree in Engineering, Science, or a related field.

• Excellent written and verbal communication skills in English, with the ability to clearly convey technical information.

• Strong attention to detail and accuracy, with the ability to review and interpret technical documents.

• Able to work independently and collaboratively in a fast-paced, dynamic environment with shifting priorities.

Preferred:

• Knowledge of quality management systems and regulatory requirements such as ISO 13485 and FDA regulations.

• Familiarity with medical device standards like ISO 14971 and IEC 60601.

• Previous experience in quality assurance within the medical device or pharmaceutical industry.

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

• Leadership skills to drive quality initiatives on a global scale.

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!