Senior Quality Specialist

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ABOUT THE ROLE

The Senior Quality Specialist is responsible for improving awareness, visibility, and communication of quality initiatives to support assigned functional, divisional and corporate quality goals, and priorities.

The role is encouraged to:

• Be autonomous, collaborative and partner with stakeholders and functions as required
• Develop, establish, and maintain quality methodologies, systems and practices which meet Boston Scientific customer and regulatory requirements.
• Lead and provide quality direction and support for improvement initiatives relating to regulatory, operational, and services.
• Engaging with cross-functional stakeholders on implementing quality processes and procedures as appropriate.

This role is based in Mascot, New South Wales and will report to the Senior Quality Assurance Manager.

• Sets the standard and demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and upholds Boston Scientific Values and Behaviors.
• Represents Boston Scientific with regulators, customers and advocacy within the industry.
• Acts as quality delegate and provides direction and leadership to the team(s) and business as required.
• Develops and champions relationships within Australia, New Zealand, APAC, and the broader global Boston Scientific organization.
• Responsible for compliance and leading core areas of Boston Scientifics Quality Management System (QMS)
• Effectively partners and collaborates with commercial and functional teams to develop and influence sound products, processes, and business-related decisions.
• Accountable for delivering and leading core quality projects and value improvement (VIP) initiatives that reduce risk, improve efficiency and add value to the organization
• Leads the business through complexities by applying risk management methodologies to events such as field actions, CAPA's (Corrective and Preventive Action) and other unforeseen quality issues
• Accountable for representing quality and providing quality direction to the business during change and growth
• Proactively communicates and presents to all levels within the organization

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

Customer Focus

• Identifies customer needs and ensures the effective delivery of high-quality solutions, products, and services that meet or exceed customer expectations.
• Consistently strives to provide high quality responses to customers
• Uses stakeholder engagement and customer feedback to identify improvement opportunities
• Takes accountability and follows up on requests from others in a timely manner

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

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.
• Uses a variety of approaches to accommodate the interpersonal styles of others
• Responds resourcefully, flexibly, and positively when faced with new challenges and demands. Moves forward productively and optimistically under conditions of change or uncertainty.
• Remains flexible when overcoming unplanned obstacles

Functional Expertise

• Stays up to date in areas of expertise and demonstrates use of that knowledge to successfully achieve goals and objectives
• Develops credibility with teammates through in-depth knowledge of issues, problems and potential solutions
• Stays up to date with new and evolving trends
• Makes sound decisions based upon knowledge and expertise

YOUR EXPERIENCE AND SKILLS

• 8+ years' experience in the medical device, healthcare or similar regulated industry
• Previous experience in a supervisory, manager role or the ability to demonstrate mentoring/coaching of team members in areas of quality
• Bachelors in STEM or a similar related degree
• Experience in leading internal audits and/or supplier audits
• Experience in facilitating external audits with certifying organisations and/or regulators.
• Subject Matter Expertise of regulations and core processes relating to Quality Systems (for example, CAPA, Nonconforming product/process, Supplier Management, Supply Chain Operations, Regulatory Approvals, Auditing, Post Market, Complaints, Field actions, Customer Feedback / Satisfaction)
• High level of communication skills both verbal and written and ability to interpret regulations and quality procedures.
• Experience leading projects, continuous improvement initiatives, Value Improvements (VIP) using Project Management and/or Lean/6-Sigma principles.
• Experience in leading a business through nonconforming events and implementation of corrective and preventive actions to mitigate and address risk.
• Well-developed people skills and ability to actively engage with stakeholders.
• Strong problem solving, organisational and execution skills.
• High attention to detail and a collaborative approach.

WHY CHOOSE US?

• Great Place To Work Certified in 2024 & 2025
• Best Workplaces for Women in 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
• Free on-site parking

Requisition ID:609759

Job Segment: Lean Six Sigma, Compliance, CAPA, Supply Chain, Management, Legal, Quality, Operations