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Associate Project Manager
vor 2 Wochen
Associate Project Manager - Quality SystemsApply locations: Sydney, NSW, Australia; Singapore, SingaporeTime type: Full timePosted on: Posted 4 Days AgoTime left to apply: End Date: February 28, 2025 (30+ days left to apply)Job requisition id: JR_036014The primary role of the Quality Assurance function is to ensure that management systems are established to enable business compliance with multiple regulatory frameworks and to support the design, development, and manufacture of products that meet our customer's quality requirements.
Key deliverables include creating and building relationships with medical device regulators in every country, ensuring timely registration to meet business needs, and being responsible for all aspects of auditing to ensure regulatory compliance, quality best practices, process improvements, and the development of supplier quality systems.
This role provides broad business technical support around QA systems and processes to the organization, leads and implements significant quality projects across the business, and creates and improves quality and business processes.
It includes global responsibility for QMS alignment across global quality systems and maintenance and security of documentation systems and record keeping.Responsibilities:Project Management Responsibilities:Manage complex, competing priorities, budget, and resources across stakeholders to achieve successful project implementation for the business.Maintain clear and timely communication of project status for stakeholders.Lead business process improvement projects requiring 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:Lead cross-functional teams, responsible for understanding, analyzing, and determining the root cause of CAPAs.Support CAPA process and lead CAPA investigations, ensuring reports meet business and external authority requirements.Maintain quality systems and supporting procedures to ensure compliance with applicable regulatory standards.Conduct and participate in internal and external Quality System audits and regulatory inspections to assess compliance with FDA regulations, ISO standards, EU MDR, and other international regulations.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.Ability to 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 relevant stakeholders.Excellent problem-solving and analytical abilities to critically analyze systems.Operate with a high level of autonomy and responsibility.Strong influencing and decision-making skills, working well with all stakeholders.Qualifications and Experience:Bachelor's Degree in Science or Engineering.3-5 years related experience in the medical device industry (e.g.
ISO 13485, 21 CFR Part 820).Project Management certification (e.g.
PMI).Preferred Qualifications:Experience managing projects from initiation to closure, balancing time, cost, and scope.
Proficient in project management methodologies and frameworks.Strong ability to systematically identify, analyze, and resolve issues, ensuring continuous improvement.Expertise in conducting Root Cause Analysis to identify systemic issues and implement corrective actions.Experience in preparing clear, concise, and accurate documentation related to quality systems and regulatory compliance.In-depth knowledge of quality systems audits with formal training and experience in conducting audits in compliance with industry standards such as ISO 9001 or ISO 13485.Previous experience in a high-volume manufacturing environment, preferably in the medical device industry.Comfortable working in fast-paced, ever-changing environments and collaborating 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.
If this sounds like the workplace for you, apply now
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