Quality Assurance Specialist

Boston Scientific; Sydney; On-site; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Great Place To Work Certified 2024/202

Best Workplaces for Women 2024/2025

2 wellbeing days per year

Discounted health insurance

Employee stock purchase plan

Job summary

Boston Scientific Gruppe is seeking a Quality Specialist in Mascot, Sydney, reporting to the Senior Quality Assurance Manager. You will drive quality initiatives, maintain regulatory alignment, and support cross-functional teams across ANZ to ensure patient safety and product quality.

You will coordinate quality activities, analyze KPIs, and contribute to continuous improvement projects while leveraging systems like Windchill, SAP, Salesforce, and TrackWise.

Qualifications

• Experience in regulated industries is highly regarded.
• Degree in Science, STEM, Life Sciences or related field.
• Experience in documenting, compiling presentations and reports.
• Familiarity with electronic systems like Windchill, SAP, Salesforce and TrackWise.

Responsibilities

• Coordinate and complete quality activities across projects, audits, and nonconformances.
• Contribute to process improvements and VIP initiatives.
• Prepare quality reports, KPIs and presentations to support decision-making.
• Maintain knowledge of quality processes and regulatory requirements.
• Act as contact for customers on quality matters and escalate issues as needed.
• Manage quality issues and implement corrective actions with stakeholders.
• Utilize Windchill, SAP, Salesforce and TrackWise for quality activities.
• Support a culture of patient safety and quality.
• Undertake other quality duties as assigned.

Skills

Regulated industry

Teamwork & collaboration

Document writing

Continuous Improvement

Project Management basics

QMS knowledge

Audits & nonconformances

MS Office

Data analytics

Stakeholder communication

Education

Science/STEM/Life Sciences degree

Tools

Windchill

SAP

Salesforce

TrackWise

Job description

Select how often (in days) to receive an alert: Create Alert

Hiring Manager: Kok Yong Theo
Recruiter: Aislinn Roche

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 encouraged 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 also part of an organization committed to demonstrating diverse and inclusive behaviors.

This role is based in Mascot, Sydney and reports to the Senior Quality Assurance Manager.

KEY RESPONSIBILITIES

• Coordinates and completes assigned quality activities across areas including quality projects, complaints, field actions, document control, audits, management review, training, supplier management and nonconformances.
• Contributes to project teams and continuous improvement initiatives, including Value Improvement Projects (VIP), identifying opportunities to improve established processes and ways of working.
• Prepares, analyses and presents quality reports, metrics, key performance indicators (KPIs) and presentations to support quality activities and decision-making.
• Develops and maintains working knowledge of relevant quality processes, regulatory requirements, and BSC global and local policies and procedures, applying these requirements in day-to-day activities.
• Acts as a point of contact for internal and external customers on assigned quality matters, responding to queries, providing relevant information and assisting with the resolution of routine issues.
• Manages assigned quality issues and nonconformances, working collaboratively with relevant stakeholders to support investigations, identify and implement corrective actions, and elevate matters to management as appropriate.
• Uses BSC electronic systems, tools and platforms such as Windchill, SAP, Salesforce and TrackWise to effectively complete and document quality activities.
• Contributes to a strong quality culture through demonstrated commitment to patient safety, product quality and BSC Core Values.
• Undertakes other Quality duties and projects as assigned from time to time.

KEY COMPETENCIES REQUIRED FOR SUCCESS

• Works effectively with others across the team to achieve goals.
• Demonstrates proficient communication, and partnership in interactions with others.

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.

Planning & Execution

• Implements initiatives and objectives that align with individual or team goals. Carries out initiatives with clear deliverables, milestones, accountabilities and measures of success
• Pursues all assignments and projects until completion, following through on assignments to ensure successful completion

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 customer needs and ensures the effective delivery of high-quality solutions, products, and services that meet or exceed customer expectations.

Courage

• Confronts problems directly, taking action and being decisive. Take risks to do what is right to achieve success.
• Speaks up and challenges the status quo, champions own ideas and those of others

Analysis

• Analyses problems and opportunities and their impact on outcomes. Takes fact-based and stakeholder information into account to make sound decisions.

YOUR EXPERIENCE AND SKILLS

• Experience working within the medical device, healthcare, pharmaceutical, or another regulated industry would be highly regarded.
• A degree in Science, STEM, Life Sciences or related discipline.
• Experience in document writing, 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.
• A general understanding of Quality Management Systems (for example ISO13485 / 9001 or a similar standard) or working within a process driven environment is highly desirable.
• 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)
• Strong organisational skills with the ability to plan and execute deliverables in a timely manner.
• Proficiency with Microsoft Office applications, particularly Excel, PowerPoint, and Word.
• Reporting, data analytics and presentation skills
• Experience communicating to multiple stakeholders

WHY CHOOSE US?

• Great Place To Work Certified in 2024 & 2025
• Best Workplaces for Women in 2024 & 2025
• Inclusive Employee Resource Groups
• 2 Wellbeing Days per year
• Discounted health insurance
• Ability to purchase additional Annual Leave
• Employee Stock Purchase Plan
• Access to Employee Assistance Program

Requisition ID:635393

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