Helen Simons Email & Phone Number

Victoria, Bc

As Director of QARA, I lead a team of QARA specialists at various levels in their career, located both in our Victoria and Toronto offices. I provide direction and leadership to the team, and interface with other departments and members of the senior management team to set priorities. I work closely with my team and provide direct mentoring to ensure the best performance. As a member of the senior management team, I provide QARA input on matters across the company and provide direction as part of management review and annual planning.I also provide projects providing guidance on regulatory matters to clients and internal teams, I do this by maintaining my current knowledge of the regulatory landscape through continual learning. Within the team I maintain a collaborative approach to problem solving to support projects in achieving their milestones and providing client value with appropriate compliance to regulatory requirements.I am very keen on business excellence and continuous improvement, and play a key role within many internal projects to bring about improvements within our systems and processes, as a stakeholder, SME and as a project manager. I work hard to promote engagement to ensure success.

Seen as a change maker within the company, I was promoted to Senior QARA Manager and given the responsibility for the QMS and also internal business processes with a view to promoting operational excellence and business efficiencies within the company. My initial task was to review, overhaul and document our project management processes and related sub processes relating to resource forecasting, project reporting and invoicing. The remit for this work covered all departments within the business and working with IT/IS to improve software systems and tools alongside processes.

Victoria, Bc

During a period where StarFish was without a QA/RA Director, I was appointed Acting QA/RA Manager, to support the QA/RA team with leadership direction and line management. This role also required me to take a place on the executive team as the Management Representative, providing reporting on quality and regulatory matters

Victoria, Bc

Senior QA/RA support to medical device and IVD product developments and maintaining and improving the QMS

Contract QA/RA support for Starfish Medical providing guidance and input into their processes and systems through auditing, reviews and system updates

In addition to my roles at StarFish Medical, I also supported their spin out company Levo Medical. Levo Medical being a product company rather than consultancy required a different approach. I maintained their QMS to QSR requirements, monitored operational activities carried out by StarFish (change control, non-conformances, build quality) and managed their production & distribution records and complaint file. I provided reporting and trending analysis. I was also responsible for approving StarFish's product releases as their client.

Quality Management of ISO 9001 & 13485 accredited systems from developing new processes and procedures to assessing current processes through audit planning and conducting internal audits, then following up on findings through robust CAPA investigations. Providing Quality Assurance support to clients in the form of documentation generation, review and general quality & regulatory guidance for consumer, medical devices, IVD and combination device development. Supporting the whole of CDP in delivering better quality projects. Supporting CDPs HFE team in implementation of BHBIA and GDPR requirements for user trials.

Business process development & documenting. Product performance analysis through excel and VBA custom functionality.

Project management of innovative product development covering a range of sectors including industrial, consumer and medical devices. Quality process development & internal auditing.

Management of aircraft maintenance paperwork and procurement of tooling for client.

CAD engineer as part of drawing office team producing drawings for shop floor.