Quality Specialist, Quality Assurance, ANZ
Boston Scientific – Sydney, NSW
$90,000
ABOUT THE ROLE
The Quality Specialist is responsible for ensuring processes are followed, improvements are implemented and supports awareness, visibility, and communication on quality initiatives across the ANZ Organization. The role is to be supportive, enthusiastic and proactive in nature to work with team members and stakeholders in maintaining quality methodologies, systems, processes and practices which meet BSC, customer and regulatory requirements. The role is part of an organization committed to demonstrating diverse and inclusive behaviors.
WHAT WILL YOU BE RESPONSIBLE FOR?
• Coordinating QA tasks and activities associated to but not limited to quality projects, complaints, field actions, document control, audits, management review, training, supplier management and nonconformances.
• Active contributor to project teams relating to continuous Improvement Initiatives and Value Improvement Projects (VIP) process improvements.
• Completes and compiles quality reports, metrics, key performance indicators (KPI’s) and presentations.
• Understands key quality processes associated to the role and maintaining currency to quality, regulatory requirements, BSC global and local policies and procedures.
• Is a point of contact for internal and external customers in responding to quality queries and troubleshooting issues.
• Manages issues and nonconformances in collaboration with others, supports investigation, corrective actions and escalates to management as required.
• Routinely uses BSC electronic systems, tools and platforms (for example Windchill, SAP, Salesforce, Trackwise)
• Goes above and beyond to demonstrate commitment to a quality culture, patient safety, product quality and BSC Core values.
• Undertakes all other duties and projects within Quality.
SKILLS AND EXPERIENCE
• Minimum 2-3 years’ experience in the medical device, healthcare industry or similar regulated environment
• Bachelor’s in science, STEM or a related degree.
• Experience in document writing, good documentation practices, compiling presentations and reports
• Experience in working within a team environment, supporting projects and a basic understanding of Continuous Improvement and Project Management initiatives is preferred but not essential.
• An understanding of Quality Management Systems (for example ISO13485 / 9001 or a similar standard)
• Experience working in a process driven environment.
• Experience of being involved in internal / external audits or managing non conformances is desirable but not essential. A sound knowledge or enthusiasm to learn electronic systems and tool applications (for example Windchill, SAP, Salesforce, Trackwise)
• Ability to organise, plan and execute deliverables in a timely manner.
• Microsoft Office Suite intermediate (Excel, PowerPoint, Word)
• Reporting, data analytics and presentation skills
• Experience communicating to multiple stakeholders
Competencies
• Relationship Building
Establishes and maintains strong relationships internally and externally. Contributes to a culture of respect, diversity, and inclusion. Earns the respect and trust of others through effective interpersonal skills, integrity and authenticity.
• Collaboration
Works effectively with others across the team to achieve goals. Demonstrates proficient communication, and partnership in interactions with others.
• Communication
Communicates effectively one-on-one and in groups. Openly shares knowledge and expertise. Listens actively and contributes to the open expression of ideas and opinions.
• Customer Focus
Identifies internal/external customer needs and ensures the effective delivery of high quality solutions, products, and services that meet or exceed customer expectations.
• Planning
Implements initiatives and plans that align with individual or team objectives. Carries out initiatives with clear deliverables, milestones, accountabilities and measures of success.
• Execution
Pursues all assignments and projects until completion. Follows through on assignments to ensure successful completion.
• Analysis
Analyses problems and opportunities and their impact on outcomes. Takes fact-based and stakeholder information into account to make sound decisions.
Boston Scientific – Sydney, NSW
$90,000
ABOUT THE ROLE
The Quality Specialist is responsible for ensuring processes are followed, improvements are implemented and supports awareness, visibility, and communication on quality initiatives across the ANZ Organization. The role is to be supportive, enthusiastic and proactive in nature to work with team members and stakeholders in maintaining quality methodologies, systems, processes and practices which meet BSC, customer and regulatory requirements. The role is part of an organization committed to demonstrating diverse and inclusive behaviors.
WHAT WILL YOU BE RESPONSIBLE FOR?
• Coordinating QA tasks and activities associated to but not limited to quality projects, complaints, field actions, document control, audits, management review, training, supplier management and nonconformances.
• Active contributor to project teams relating to continuous Improvement Initiatives and Value Improvement Projects (VIP) process improvements.
• Completes and compiles quality reports, metrics, key performance indicators (KPI’s) and presentations.
• Understands key quality processes associated to the role and maintaining currency to quality, regulatory requirements, BSC global and local policies and procedures.
• Is a point of contact for internal and external customers in responding to quality queries and troubleshooting issues.
• Manages issues and nonconformances in collaboration with others, supports investigation, corrective actions and escalates to management as required.
• Routinely uses BSC electronic systems, tools and platforms (for example Windchill, SAP, Salesforce, Trackwise)
• Goes above and beyond to demonstrate commitment to a quality culture, patient safety, product quality and BSC Core values.
• Undertakes all other duties and projects within Quality.
SKILLS AND EXPERIENCE
• Minimum 2-3 years’ experience in the medical device, healthcare industry or similar regulated environment
• Bachelor’s in science, STEM or a related degree.
• Experience in document writing, good documentation practices, compiling presentations and reports
• Experience in working within a team environment, supporting projects and a basic understanding of Continuous Improvement and Project Management initiatives is preferred but not essential.
• An understanding of Quality Management Systems (for example ISO13485 / 9001 or a similar standard)
• Experience working in a process driven environment.
• Experience of being involved in internal / external audits or managing non conformances is desirable but not essential. A sound knowledge or enthusiasm to learn electronic systems and tool applications (for example Windchill, SAP, Salesforce, Trackwise)
• Ability to organise, plan and execute deliverables in a timely manner.
• Microsoft Office Suite intermediate (Excel, PowerPoint, Word)
• Reporting, data analytics and presentation skills
• Experience communicating to multiple stakeholders
Competencies
• Relationship Building
Establishes and maintains strong relationships internally and externally. Contributes to a culture of respect, diversity, and inclusion. Earns the respect and trust of others through effective interpersonal skills, integrity and authenticity.
• Collaboration
Works effectively with others across the team to achieve goals. Demonstrates proficient communication, and partnership in interactions with others.
• Communication
Communicates effectively one-on-one and in groups. Openly shares knowledge and expertise. Listens actively and contributes to the open expression of ideas and opinions.
• Customer Focus
Identifies internal/external customer needs and ensures the effective delivery of high quality solutions, products, and services that meet or exceed customer expectations.
• Planning
Implements initiatives and plans that align with individual or team objectives. Carries out initiatives with clear deliverables, milestones, accountabilities and measures of success.
• Execution
Pursues all assignments and projects until completion. Follows through on assignments to ensure successful completion.
• Analysis
Analyses problems and opportunities and their impact on outcomes. Takes fact-based and stakeholder information into account to make sound decisions.
