Quality Assurance Specialist

Boston Scientific; Sydney; On-site; AUD 90,000 - 115,000; Full time

Benefits offered by this job

Great Place To Work Certified

Best Workplaces for Women

Employee Stock Purchase Plan

Wellbeing days

Job summary

Boston Scientific in Mascot, Sydney seeks a Quality Specialist to ensure processes are followed, drive improvements and support quality initiatives across ANZ. The role is based in Mascot, reporting to the Senior Quality Assurance Manager.

You will work with Windchill, SAP and TrackWise to manage quality activities, audits and nonconformances, while preparing reports and metrics for decision-making. A proactive, collaborative approach and regulatory awareness are essential.

Qualifications

• Experience in the medical device, healthcare, or regulated industries preferred.
• Degree in Science, STEM, Life Sciences or related discipline.
• Experience in writing documents, compiling presentations and reports.
• Team-based work with exposure to Continuous Improvement or Project Management is a plus.
• Understanding of Quality Management Systems (e.g., ISO13485/9001) desirable.
• Experience with internal/external audits or nonconformances is a plus.
• Familiarity with electronic systems such as Windchill, SAP, Salesforce or TrackWise.

Responsibilities

• Coordinate and complete quality activities across projects, complaints, field actions, audits and nonconformances.
• Contribute to continuous improvement initiatives, VIPs and process optimization.
• Prepare and present quality reports, KPIs and data for decision-making.
• Maintain knowledge of quality processes and regulatory requirements.
• Act as a contact for customers on quality matters and assist with issue resolution.
• Manage quality issues with stakeholders to implement corrective actions and escalations as needed.

Skills

Regulated industry experience

Documentation & reporting

Excel

PowerPoint

Word

Communication

Audits & nonconformances

Continuous Improvement

Education

Science/Life Sciences degree

Tools

Windchill

SAP

TrackWise

Salesforce

Job description

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 escalations 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

Collaboration

• 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.

C ourage

• 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 conformance 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