SIMON ANSELL
Perth,WA
Summary
Quality assurance and regulatory affairs expert with extensive experience in medical devices, pharmaceuticals, and service industries. Proven track record in implementing quality management systems that enhance compliance and operational excellence. Strong leadership in fostering strategic partnerships and executing disciplined quality initiatives.
Overview
1
1
Certification
12
12
years of professional experience
Work History
Head Of Quality Assurance & Regulatory Affairs
Gene S Pty Ltd
Perth, WA
08.2025 - Current
- Lead the Quality Assurance and Regulatory Affairs function, providing strategic oversight of Quality Management System (QMS) compliance across the full medical device product lifecycle.
- Direct the development, implementation, maintenance, and continuous improvement of an ISO 13485-compliant QMS aligned with ISO 14971, EU MDR, MDSAP, and TGA regulatory requirements.
- Oversaw regulatory submissions, product registrations, technical documentation, and lifecycle maintenance with TGA, and international regulatory authorities to ensure compliance and facilitate market access.
- Established CAPA, risk management, supplier quality, and post-market surveillance frameworks that enhanced product quality and ensured compliance with regulatory standards.
- Collaborated with senior management, regulatory authorities, certification bodies, authorised representatives, and external stakeholders to align regulatory compliance efforts with business growth objectives.
- Implemented & transitioned the business to an Electronic QMS
Head of Quality, Service & Training Manager
Alcolizer Technology Pty Ltd
Balcatta, Australia
04.2021 - 08.2025
- Accountable for the effectiveness, efficiency and continuous improvement of the ISO 9001 Quality Management System, including timely publication, approval and availability of controlled policies, procedures and quality documentation.
- Led quality assurance initiatives to enhance product compliance with industry standards.
- Increased first-pass quality rates by 25% by implementing enhanced training programs for manufacturing staff
- Improved customer satisfaction scores by 15% by optimizing service delivery timelines
- Develop strategies to boost customer satisfaction and refine processes
- Lead, motivate, and develop the national service teams, fostering a culture of excellence, accountability, and continuous learning
- Led initiatives to foster excellence and continuous improvement across the organization
- Provided expert recommendations on policy and process improvements to enhance operational effectiveness
- Implemented ISO 27001 to align the business to international security compliance
QA / RA Advisory Board Member
Gene S Pty Ltd
Perth, Australia
06.2021 - 08.2025
- Aligned QA/RA requirements with organizational goals to enhance regulatory compliance and strategic objectives
- Oversaw compliance for medical devices, ensuring all met TGA standards
- Mentored team members on QA/RA best practices, providing guidance on resolving various QA/RA challenges
- Supported implementation of Quality Management System for new medical device startup, ensuring compliance and operational readiness
QA Change Management Professional
Pfizer
Bentley, Australia
03.2020 - 04.2021
- Delivered critical changes on time to support business continuity
- Delivered on my CAPA actions to reduce recurring issues
- Coordinate and monitor the progress and effectiveness of CAPA related actions
- Reduced overdue change actions within the blow fill seal department by over 40% in 6 months
- Supported the business in OOE improvement - implemented additional equipment to reduce the need for line stoppages and resteam (cleaning process)
- Improved incoming product supply to reduce cost and waste
- Communicated with production areas to coordinate workflow and ensure efficiency. and other departments to ensure that assigned change management and documentation tasks are completed on time and compliantly
- Update allocated metrics and status of assigned actions/projects to ensure completion targets are met
- Lead site change management meetings with senior leadership team
Quality Assurance Coordinator
CareDx Pty Ltd
Fremantle, Australia
01.2016 - 03.2020
- Worked with the senior QA/RA manager to develop, implement and maintain the Quality Management System
- Ensured systems implemented, including deviation and change management, meet continued compliance of national and international standards including ISO13485 - 2016
- Managed the NCR process, ensuring appropriate corrective actions are taken for product release and preventing repeat occurrences
- Managed NCRs in a timely manner to achieve site KPIs
- Identified, suggested and led reliable site improvement initiatives, using a risk-based approach to prioritize change
- Worked closely with manufacturing and research and development teams to ensure compliance with cGMP and cGDP requirements
- Reported weekly to the senior management team and key business stakeholders on the performance of the QMS
Quality Operations Team Leader
Smith + Nephew AWM
Kingston upon Hull, United Kingdom
06.2014 - 04.2018
- Supported the Quality Department to manage and lead a Quality Operations Team in global operations manufacturing facility
- Led the Quality and Production Team through effective training and coaching to provide continuous improvement of processes, products and manufacturing controls
- 2015 Food and Drugs Administration audit lead for deviations, reducing site open deviations and Non-Conformance Reports from 1600 to 500, a reduction of 76% within 4 weeks
- Implemented a robust customer complaints process using Lean Six Sigma Green Belt methodology, leading to a reduction of raised complaints and resulting in savings of $900k+ yearly, with additional savings of $400k in 2017
- Ensured close coordination was maintained between manufacturing, quality and external customers, to enhance customer service and satisfaction while meeting regulatory compliance requirements
- Delivered quality improvements to establish a sustainable process
- Created and implemented a successful Quality Impact Assessment Form for immediate assessment of issues, providing swift action advice
Education
Lean Sigma Manufacturing - Green Belt -
Smallpiece Enterprise Ltd
Kingston upon Hull, United Kingdom12-2017
ISO 13485:2016 Medical Devices -
BSI
Kingston upon Hull, United Kingdom05-2016
NVQ Process Operator -
Holiday Pigments
Kingston upon Hull, United Kingdom01-2007
BTEC National Diploma - Sports Science
Riley College
Kingston upon Hull, United Kingdom06-1999
Skills
- Quality Assurance
- Regulatory Affairs
- GMP
- GDP
- QMS
- CAPA processes
- Risk management
- Regulatory adherence
- TGA
- FDA
- Medical Devices
- Quality control
- Change management
- Continuous improvement
- Supplier quality management
- Quality control systems
- GMP auditing
- Internal Audit
- FMEA
- Technical documentation
- Document management
- Quality processes
- Quality metrics
- Preventive measures
- Complaint resolution
- Process Optimization
- KPI
- Leadership
- Change management
- Document control
Accomplishments
- Led the successful completion of Stage 1 MDSAP QMS implementation, establishing a globally aligned quality framework supporting ISO 13485, TGA, and international regulatory compliance.
- Implementation of and business transition to Electronic QMS.
- Achievements in FDA Audit: Reduced site deviations by 76% within four weeks during the FDA audit.
- Reduced Overdue Changes: Achieved a 40% reduction in overdue change actions within six months at Pfizer.
- Lean Six Sigma Implementation: Implemented Lean Six Sigma processes, saving over $900,000 annually in complaint management.
- Developed a health initiative, raising $200,000 over two years for More Together.
- Service budget: Increased service revenue by $1 million (25% above FY24 budget) through direct customer communication and one-on-one support.
Certification
- ISO 13485:2016 - Medical Devices QMS, Transition, and Auditor Refresher Training
- ISO 9001:2015 - Quality Management System
- Lean Sigma Manufacturing - Green Belt
- IOSH (Institution of Occupational Safety and Health) - Managing Safely
- Internal Auditing Training
- Les Mills BODYCOMBAT Certified Group Fitness Instructor
Timeline
Head Of Quality Assurance & Regulatory Affairs
Gene S Pty Ltd
08.2025 - Current
QA / RA Advisory Board Member
Gene S Pty Ltd
06.2021 - 08.2025
Head of Quality, Service & Training Manager
Alcolizer Technology Pty Ltd
04.2021 - 08.2025
QA Change Management Professional
Pfizer
03.2020 - 04.2021
Quality Assurance Coordinator
CareDx Pty Ltd
01.2016 - 03.2020
Quality Operations Team Leader
Smith + Nephew AWM
06.2014 - 04.2018
Lean Sigma Manufacturing - Green Belt -
Smallpiece Enterprise Ltd
ISO 13485:2016 Medical Devices -
BSI
NVQ Process Operator -
Holiday Pigments
BTEC National Diploma - Sports Science
Riley College