Total 4 qa specialist job vacancies in Sydney Olympic Park

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.

Clinical Specialist, Electrophysiology
Boston Scientific
Sydney, NSW
$80,000 +



ABOUT THE ROLE
Our elite sales team is made up of passionate, dedicated professionals, delivering the most advanced medical technologies to patients in need. By collaborating extensively with leading healthcare professionals you’ll see first-hand the impact you have on individual lives - one patient at a time.
The position of Clinical Specialist, Electrophysiology (EP), provides field/remote clinical, technical & educational support in EP to assigned accounts across ANZ. The primary focus is to support new therapy introduction of Pulsed Field Ablation through our recent launch of the FARAPULSE™ system, demonstrating clinical expertise to influence superior outcomes. Frequent travel will be required as part of the role.

WHAT WILL YOU BE REPONSIBLE FOR?
• Utilising your technical knowledge of:
o The field of electrophysiology (including propagation of electrical circuits within cardiac tissue and the pathophysiology of electrical rhythm disorders), biophysics of radiofrequency, cryo-thermal ablation, 2D and 3D electroanatomical mapping principles to provide:
? Clinical support including basic trouble-shooting, and clinical guidance to diagnose and treat cardiac arrhythmias
? Provide the measurement of electrical circuits within the heart and perform stimulation protocols as per physician requests to measure the electrical conductivity of the heart to aid in the diagnosis of cardiac arrhythmias
? Develop a deep technical understanding of, and provide the technical training of company products to Cardiac Electrophysiologists, Cardiac Physiologists and Nurses
• Travelling as required to meet customer demand for the services described above.
• Attending cases face to face (or remotely) with customers, operating Boston Scientific products where appropriate, and providing detailed training / advice to physicians on clinical attributes / techniques associated with Boston Scientific electrophysiology products including:
o Providing clinical support for: FARAPULSE™, POLARx™, RHYTHMIA™, LAB SYSTEM PRO™, MAESTRO 4000™, METRIQ™, plus support for the full range of Boston Scientific EP Catheters
• Developing deep understanding on the workflows and specificities of each hospital & business relationships with hospital personnel (e.g., through informal conversation, meetings, participation in conferences) to make new contacts in other departments within hospital and all stakeholders to ensure that products are trained and utilised in accordance with the Directions for Use.
• Ensuring timely collection, reporting of all required medical documentation pertaining to our procedural device operation.
• Responding to complex customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel (e.g., sales, clinical, research, marketing, technical support) to develop optimal solutions.
• Recording customer information and activities in company’s CRM system: use the system as an alignment tool with other commercial roles.
• Completion of relevant administration including reporting, stock validations and inventory management
• Attending meetings, conferences and exhibitions as required to promote Boston Scientific products and services.
• Being available to support the broader ANZ Rhythm Management business on an as-needs basis

KEY COMPETENCIES REQUIRED FOR SUCCESS
Product/Technical Knowledge
• A thorough understanding of Cardiac Electrophysiology
• Biophysics of radiofrequency and cryoablation
• A thorough understanding of Pulsed Field Ablation (Pulsed Direct Current) on cardiac tissue and a biophysical understanding of tissue selectivity
• Successfully completes all relevant training.
• Develop in depth knowledge of electrophysiology procedure, products and treatment applications.
• Proactively keeps up to date with technical knowledge in electrophysiology.
Relationship Building
• Builds and maintains effective networks that add value in achieving work related goals.
• Skilled in building rapport with a wide variety of individuals.
• Understands the balance between taking time to build rapport and achieving objectives set.
• Works effectively and collaboratively within the team environment.
Organisation & Reporting
• Maintains well organised materials, files, system and reports.
• Plans and prioritises territory activity.
• Makes sure all parts of a job are completed in full, within deadlines, including follow-up plans and documentation.
Results Focused
• Demonstrates a growth mindset.
• Measures own performance and seeks feedback for self-development
• Demonstrates resilience and has a strong sense of urgency
• Recognises and acts on opportunities.
• Maintains a flexible approach to meet goals.
SKILLS AND QUALIFICATIONS
• Previous clinical case experience within electrophysiology / rhythm management essential
• Strong technical and clinical skills
• Proven experience in building and maintaining customer relationships.
• Proven ability to absorb complex technical information and apply this knowledge in the field.
• Excellent written & verbal communication.
• Tertiary qualifications in preferred disciplines including biomedical engineering and science-related disciplines.
• Exposure and understanding of conventional EP. Ability to interpret EP signals. Exposure to 3D Mapping and cryoablation. Troubleshooting skills and experience
• Desired qualifications IBHRE EP, IBHRE Pacing

Clinical Specialist, Electrophysiology & Rhythm Management
Boston Scientific
Sydney, NSW
Starting at $85,000 + Super

ABOUT THE ROLE?


Our elite sales team is made up of passionate, dedicated professionals, delivering the most advanced medical technologies to patients in need. By collaborating extensively with leading healthcare professionals you’ll see first-hand the impact you have on individual lives - one patient at a time.??

The position of Clinical Specialist, Electrophysiology will support the business in achieving sales targets, goals, and objectives of the division; to aid the achievement of customer satisfaction and business growth through focused business planning; and to support customers with clinical expertise to enable optimal patient outcomes.

This role will be responsible for overseeing a VIC region and reports directly into the Sales Manager, Electrophysiology.?


WHAT WILL YOU BE REPONSIBLE FOR??


Develop and execute on territory plans to deliver on annual revenue commitments and build a sustainable long-term business?

Build strong relationships with existing customers, plan and develop the market for our existing and new products in line with divisional goals and objectives?

Successfully complete the internal Electrophysiology training program, apply these skills in the field and maintain high level of technical and market knowledge on an ongoing basis?

Provide clinical support for: RHYTHMIA™, POLARx™, LAB SYSTEM PRO™, MAESTRO 4000™, METRIQ™, plus support for the full range of Boston Scientific EP Catheters.???

The NSW territory, however, you will work with the other NSW Clinical Product Specialists, the RHYTHMIA Sales and Training Specialist to help support the NSW territory, as well as the broader Electrophysiology team to identify sales, training, and engagement opportunities for new and existing customers.?

Have sound business knowledge of territory, identifying competitor activities, participate and manage appropriate tender agreements and customer policies and practices. Completing market analysis and regular reporting as required.?

Completion of relevant administration including reporting, stock validations and management as well as database management.??

Established contact person for hospital management, purchasing department and hospital staff as it relates to BSC's Electrophysiology business.??

Become expert in Salesforce CRM software & e-Detailing platforms?

Attending meetings, conferences and exhibitions as required, to promote our products and services.?

To be available to support the broader ANZ EP business on an as-needs basis.?


KEY COMPETENICES REQUIRED FOR SUCCESS?
?
- 5 + Years' Experience in Clinical Support for Electrophysiology?
- 5 + Years' 3D Electroanatomical Mapping?
- Bachelor of Engineering or Equivalent ?
?
Operation of 3D Electroanatomical Mapping System?


Familiar with, and complete required training on the equipment including software and hardware functionality, connections between modules, integration with other operating room equipment.?

Surgical procedure, the Boston Scientific representative is required to operate the medical equipment according to IFU guidelines, that is used to diagnose and treat cardiac arrhythmias, working synergistically with the Cardiac Electrophysiologist, assist in the generation of 3D electroanatomical maps, consistent with a cardiac arrhythmia procedure?

Troubleshoot the equipment should errors arise with software or hardware components of the system during a medical procedure including software and hardware errors, connections between the equipment and the patient, electrical interference with other electrical equipment within the operating room?

Provide on-site response and corrective action for the equipment ?

Provide clinical guidance on the 3D electroanatomical map ?

Install software upgrades on the 3D electroanatomical mapping system where required, and work as project manager with both installing biomedical engineers and cable installers when new equipment is installed in hospitals?
?

Operation of Radiofrequency Generator and peristaltic pump
?

Be familiar with the biophysics of radiofrequency ablation in advance of procedures?

Ensuring the correct functioning of the generator during a procedure?

Operate the system within IFU guidelines?

Provide real-time feedback to the physician of the systems functionality within established parameters?

Troubleshoot and provide corrective action of the equipment during a procedure?
?

Operation of the Cryoablation Generator?


Experience with the mechanics of the cryoablation generator?

Monitor the system’s performance throughout the medical procedure, ensuring correct gas pressures, balloon pressures, temperature and system functionality?

Provide real-time feedback to the physician at all times that the system is functioning within established parameters?

Respond to alerts and provide technical advice throughout the medical procedure?

Provide clinical guidance on the performance of the system mid-procedure?
?

Operation of the Pulsed Field Ablation Generator?


Biophysics of Pulsed Field Ablation and the generator specifically, and it’s working parameters?

Experience with operating the system within the IFU guidelines?

Experience Informing Physicians when the system is ready to deliver Pulsed Electrical Fields?

Monitor performance of, and responding to errors in the system?

Provide functional response when errors require intervention during a procedure?

Provide clinical guidance of the system mid-procedure

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.