Quality Systems Engineer - CAPA & Projects

The primary role of Quality Assurance function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer’s quality requirements. Key deliverables include creating and building relationships with medical device regulatory in every country. Ensure timely registration to meet business needs. Also, responsible for all aspects of auditing to ensure regulation compliance, quality best practice, process improvements and development of supplier quality systems. Provides broad business technical support around QA systems and processes to the organization. Leads and implements significant quality projects across the business and also creates and improves quality and business processes. Capability and process development for compliance and Continuous improvement. Global responsibility for QMS alignment across global quality systems. Maintenance and security of documentation system and record keeping.

Let’s talk about Responsibilities:

Project Management Responsibilities:

• Manages complex, competing priorities, budget and resources across stakeholders to achieve successful project implementation for the business.
• Responsible for maintaining clear and timely communication of project status for the stakeholders.
• Lead business process improvement projects that require a high level of technical/process analysis skills for the quality department.
• Establish clear targets and design concepts for projects and drive change management as required.

CAPA Responsibilities:

• Leads cross-functional teams, responsible for understanding, analysing and determining the root cause of CAPAs.
• Support CAPA process and lead CAPA investigations and ensure reports meet the requirements of the business and external authorities.
• Maintain quality systems and supporting procedures to ensure that ResMed quality systems comply with the requirements and intent of the applicable regulatory standards.
• Conducts and participates in internal and external Quality System audits and regulatory inspections to assess the compliance with FDA regulations, ISO standards, EU MDR, and any other international regulations and internal requirements.
• Apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Perform other ad hoc duties as required.

Position Specific Skills and Challenges

• Project Management skills, including planning, organisation and delegation.
• Lead and influence others across multiple time zones and locations.
• Independent problem-solving skills, self-direction and excellent organisational skills.
• Excellent communication skills, particularly in understanding the level of information required by various stakeholders.
• Recognize, analyze and implement opportunities for cross-business collaboration and process improvements.

• Good conceptual thinking ability, ability to summarise, recommend and present to the relevant stakeholders.

• Excellent problem solving and analytical abilities to critically analyse systems.
• Operate with a high level of autonomy and responsibility.   
• Have strong influencing and decision-making skills and work well with all stakeholders.

Let’s talk about Qualifications and Experience

Minimum

• Bachelor’s degree in science or engineering.

• 3-5 years related experience in medical device industry e.g ISO 13485, 21 CFR Part 820.
• Project management certification e.g. PMI

Preferred (Qualifications/experiences that are preferred for the position)

• Technical Writing Training.
• Problem Solving Training.
• Formal Training in Quality Systems audits.
• Project Management Experience.
• Previous experience in a high-volume manufacturing environment, preferably Medical Device.
• Ability to work in a diverse and dynamic environment.

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!