Boston Scientific
Sydney, NSW
ABOUT THE ROLE
The Senior Quality Specialist is responsible to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals, and priorities. The role is encouraged to be autonomous, collaborating and partners with team members to recommend, design and implement functional process improvements. Develops, establishes, and maintains quality methodologies, systems and practices which meet BSC, customer and regulatory requirements. Provides compliance guidance and support for process development concepts, regulatory, operational, or systems/services and engage with cross-functional stakeholders on implementing quality processes and procedures as appropriate.
Business Partnering and Key Responsibilities:
• Develops internal / external global relationships in Australia and New Zealand, APAC and the wider global Boston organization. Champions these relationships to identify needs and drive systematic changes to achieve strategic objectives
• Effectively partners with commercial and functional teams to develop and influence sound product and business strategies
• Influences unique and creative solutions to meet quality, customer, and business needs
• Incorporates quality objectives and initiatives into business strategies and needs to provide value to the organization
• Establishes strategic alliances and influences direction of internal and external policies impacting ANZ business
SKILLS & KEY COMPETENICES
Experience
• 6+ years’ experience in the medical device, healthcare industry or similar regulated environment
• Ideally 2+ years’ experience with mentoring/coaching team members and functions on all areas of quality
• Bachelor’s in science or a related degree is desirable
• Experience in Lean / 6 Sigma, Project Management or equivalent is desirable
• In depth understanding of Quality Management System regulations and principles (for example ISO13485 / 9001) as they apply to the entire product lifecycle, including planning, product realisation, measurement / analysis, and feedback.
• Demonstrated success dealing with multiple stakeholders across all levels of an organisation including key suppliers and vendors
• Experience in leading internal audits and supporting external regulator / supplier audits
• Experience leading projects, continuous improvement, Value Improvement (VIP) and demonstration of Project Management, Lean, 6-Sigma principles
• Sound knowledge of Risk Management methodologies
• Understanding of core processes relating to Quality Systems (for example, CAPA, NCEP nonconforming management, Supplier Management, Auditing, complaints, field actions, customer satisfaction)
• Promoting a positive Quality Culture within the organization with a “Can do” and positive attitude
• Experience working on site or remotely
Skills
• High level of communication skills both verbal and written and ability to interpret regulations and quality procedures.
• Well-developed interpersonal skills, a collaborative approach and ability to actively engage all stakeholders
• Strong problem solving and negotiation skills
• High attention to detail and collaborative approach
• Comfortable operating within a complex and fast paced self-directed environment
• Ability Apply risk management methodology when needed
• Ability to “Project Manage” multiple key projects and initiatives at one time
• Microsoft Office Suite intermediate to advance level
• Strong reporting, data analytics and presentation skills
• Sound knowledge of using electronic systems and tool applications (for example Windchill, SAP, Salesforce, Trackwise)
Competencies
• Ability to quickly establish effective relationships
• Being “Customer Focused” and understanding when to identify and escalate issues
• Maximises value through development of innovative quality solutions
• Influences outcomes through knowing who to involve and when
• Uses a team approach to solve problems and maximise opportunities
• Effectively deals with conflict and maintains calm under pressure
• Ability to lead courageously by confronting problems directly, taking action and being decisive, even when it may be challenging but the right thing to do
• Ability to respond resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands.
QUALITY SYSTEM REQUIREMENT
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Sydney, NSW
ABOUT THE ROLE
The Senior Quality Specialist is responsible to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals, and priorities. The role is encouraged to be autonomous, collaborating and partners with team members to recommend, design and implement functional process improvements. Develops, establishes, and maintains quality methodologies, systems and practices which meet BSC, customer and regulatory requirements. Provides compliance guidance and support for process development concepts, regulatory, operational, or systems/services and engage with cross-functional stakeholders on implementing quality processes and procedures as appropriate.
Business Partnering and Key Responsibilities:
• Develops internal / external global relationships in Australia and New Zealand, APAC and the wider global Boston organization. Champions these relationships to identify needs and drive systematic changes to achieve strategic objectives
• Effectively partners with commercial and functional teams to develop and influence sound product and business strategies
• Influences unique and creative solutions to meet quality, customer, and business needs
• Incorporates quality objectives and initiatives into business strategies and needs to provide value to the organization
• Establishes strategic alliances and influences direction of internal and external policies impacting ANZ business
SKILLS & KEY COMPETENICES
Experience
• 6+ years’ experience in the medical device, healthcare industry or similar regulated environment
• Ideally 2+ years’ experience with mentoring/coaching team members and functions on all areas of quality
• Bachelor’s in science or a related degree is desirable
• Experience in Lean / 6 Sigma, Project Management or equivalent is desirable
• In depth understanding of Quality Management System regulations and principles (for example ISO13485 / 9001) as they apply to the entire product lifecycle, including planning, product realisation, measurement / analysis, and feedback.
• Demonstrated success dealing with multiple stakeholders across all levels of an organisation including key suppliers and vendors
• Experience in leading internal audits and supporting external regulator / supplier audits
• Experience leading projects, continuous improvement, Value Improvement (VIP) and demonstration of Project Management, Lean, 6-Sigma principles
• Sound knowledge of Risk Management methodologies
• Understanding of core processes relating to Quality Systems (for example, CAPA, NCEP nonconforming management, Supplier Management, Auditing, complaints, field actions, customer satisfaction)
• Promoting a positive Quality Culture within the organization with a “Can do” and positive attitude
• Experience working on site or remotely
Skills
• High level of communication skills both verbal and written and ability to interpret regulations and quality procedures.
• Well-developed interpersonal skills, a collaborative approach and ability to actively engage all stakeholders
• Strong problem solving and negotiation skills
• High attention to detail and collaborative approach
• Comfortable operating within a complex and fast paced self-directed environment
• Ability Apply risk management methodology when needed
• Ability to “Project Manage” multiple key projects and initiatives at one time
• Microsoft Office Suite intermediate to advance level
• Strong reporting, data analytics and presentation skills
• Sound knowledge of using electronic systems and tool applications (for example Windchill, SAP, Salesforce, Trackwise)
Competencies
• Ability to quickly establish effective relationships
• Being “Customer Focused” and understanding when to identify and escalate issues
• Maximises value through development of innovative quality solutions
• Influences outcomes through knowing who to involve and when
• Uses a team approach to solve problems and maximise opportunities
• Effectively deals with conflict and maintains calm under pressure
• Ability to lead courageously by confronting problems directly, taking action and being decisive, even when it may be challenging but the right thing to do
• Ability to respond resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands.
QUALITY SYSTEM REQUIREMENT
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
