Katie Stephens
Chippendale,New South Wales
Summary
Quality Assurance professional with experience across medical devices and regulated manufacturing environments. Experienced in complaint investigations, CAPA, post-market surveillance, regulatory compliance and audit support within ISO 13485 and TGA-regulated settings. Proven ability to manage high-volume complaint portfolios, support regulatory audits and drive continuous improvement initiatives.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Quality Assurance Complaints Officer
MULTIGATE MEDICAL PRODUCTS
05.2024 - Current
- KEY ACHIEVEMENTS
- Manage and investigate over 500 customer complaints annually across a diverse medical device portfolio.
- Support TGA and ISO 13485 audits through audit preparation, evidence collation and corrective action implementation.
- Release finished goods following review of sterilisation reports and supporting quality documentation.
- Generate and review Certificates of Analysis (COAs) to support compliant product release activities.
- Lead CAPA and non-conformance investigations to identify root causes and drive quality improvements.
- RESPONSIBILITIES
- Conduct complaint investigations in accordance with ISO 13485, regulatory requirements and internal quality procedures.
- Perform risk assessments, reportability evaluations and root cause investigations.
- Support post-market surveillance activities and regulatory reporting requirements.
- Analyse complaint trends and quality metrics to identify systemic issues and improvement opportunities.
- Collaborate with customers, suppliers and cross-functional teams to resolve quality-related issues.
- Maintain quality records and complaint documentation using Qualio, D365 and HubSpot.
Specifications & Legal Compliance Manager
SEAN LOUGHNANE'S LTD
02.2022 - 04.2024
- Managed product specifications, compliance documentation and ingredient declarations.
- Reviewed product artwork and labelling to ensure regulatory compliance.
- Coordinated new product development projects from concept through commercial launch.
- Supported BRC and Bord Bia audits and maintained audit readiness.
- Conducted product validation, benchmarking and sensory evaluation activities.
Traceability & Reconciliations Administrator
OLIVER CARTY LTD
04.2022 - 12.2022
- Managed traceability systems and reconciliations to support product integrity and regulatory compliance.
- Maintained compliance documentation and reporting records.
- Improved document control and record management processes.
Education
Bachelor of Science (Honours) - Food Science, Nutrition & Business Management
St Angela's College
SligoSkills
- ISO 13485 Compliance
- TGA Compliance
- Complaint Investigations
- CAPA Management
- Post-Market Surveillance
- Non-Conformance Management
- Root Cause Analysis
- Risk Assessment
- Product Release
- Sterilisation Review
- COA Review
- Internal & External Audits
- Quality Systems
- Continuous Improvement
- Qualio
- Microsoft Dynamics 365 (D365)
- HubSpot
- Point74
- Microsoft Office Suite
- Report writing
- Investigation management
- Data analysis
- Mentoring and training
- Root-cause analysis
Accomplishments
- Awarded Best Sensory Attributes Product (2022) for developing a product that achieved the highest sensory evaluation scores, demonstrating strong attention to quality standards and product assessment.
- Raised €2000 for Jigsaw mental health company through a digital marketing campaign, showcasing project management, teamwork and communication skills.
Certification
- ISO 13485 Internal Auditor Training
- TGA & ISO 13485 Audit Participation
- CPR Certification
- Manual Handling Training
Timeline
Quality Assurance Complaints Officer
MULTIGATE MEDICAL PRODUCTS
05.2024 - Current
Traceability & Reconciliations Administrator
OLIVER CARTY LTD
04.2022 - 12.2022
Specifications & Legal Compliance Manager
SEAN LOUGHNANE'S LTD
02.2022 - 04.2024
Bachelor of Science (Honours) - Food Science, Nutrition & Business Management
St Angela's College