Associate Project Manager - Quality Systems

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, analyzing 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, organization and delegation.

• Lead and influence others across multiple time zones and locations.

• Independent problem-solving skills, self-direction and excellent organizational 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 summarize, recommend and present to the relevant stakeholders.

• Excellent problem solving and analytical abilities to critically analyze 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):

Project Management Skills

• Experience managing projects from initiation to closure, balancing time, cost, and scope. Proficient in project management methodologies and frameworks, with the ability to effectively plan, execute, and deliver successful projects.

​Problem-Solving Skills

• Strong ability to systematically identify, analyze, and resolve issues, ensuring continuous improvement in both processes and product quality. ​

Root Cause Analysis (RCA)

• Expertise in conducting Root Cause Analysis to identify systemic issues, implement corrective actions, and prevent recurrence. Proven track record in improving product quality and regulatory compliance.

Technical Writing Training

• Experience in preparing clear, concise, and accurate documentation related to quality systems, regulatory compliance, and process improvements.

Formal Training in Quality Systems Audits

• In-depth knowledge of quality systems audits, with formal training and experience in conducting internal and external audits in compliance with industry standards such as ISO 9001, ISO 13485, or equivalent.

Experience in High-Volume Manufacturing Environments

• Previous experience in a high-volume manufacturing environment, preferably in the medical device industry, though experience in other regulated industries will also be considered.

Ability to Work in a Diverse and Dynamic Environment

• Comfortable working in fast-paced, ever-changing environments. Demonstrated ability to collaborate effectively with cross-functional and global teams.

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!