Ian Lamond Email & Phone Number

Livingston

Livingston, United Kingdon

Livingston, United Kingdom

Glasgow, United Kingdom

Nonconformity and Corrective Action – Lead responsibility for the NC and CAPA process within the organisation with responsibility for ensuring adequate and timely investigations, implementation of corrective actions, tracking and reporting of NCs and CAs.Successfully overhauled the previous system by designing and transitioning to a Microsoft Access database system enabling automated trending and greater accessibility to the information.Training – Management of internal training system reporting on employee training to employees and line managers. Responsible for release of new training modules, tracking training from document revision and communication of new training.Internal Audit – Internal auditor responsible for assessing the QMS to internal procedures and ISO 13485; duties include preparation of agenda, audit plan, audit execution, preparation of audit report and review of any subsequent corrective action plan. Additionally provide review and approval of audit findings and corrective actions generated by other auditors.Supply Chain Management – Control of approved suppliers list and associated QMS documentation ensuring adequate review and controls are implemented. Duties include coordinating with Purchasing team on supplier reviews, quality certification expiry for suppliers, trending supplier performance and introduction of new approved suppliers. Document Control – Preparation of document templates, oversight of technical team documentation through the QMS document release process; including review and subsequent approval. Ensuring QMS documentation and quality records are accurate and adequately controlled. Storage, archival, and when required, retrieval of QMS documentation.QMS Reporting – Monitor QMS performance through gathering relevant data and preparation of presentation slides trending KPIs and reporting overall QMS metrics for delivery to Senior Management Team. Distribution and communication of key metrics to the organisation.

Inverness, United Kingdom

Six sigma trained Green Belt with substantial practice of utilising process excellence tools and statistical methods in support of process improvements. Conversant with analysis of variance, ANOVA gauge R&R, CTQ tree, SIPOC, FMEA and test method technical assessment.Comprehensive experience of creating and revising documentation in support of process and equipment development in an FDA and CE regulated medical device environment.Familiar with validation of computer software/systems and writing supporting documents ensuring compliance with 21 CFR Part 11 and Part 820.Successfully completed concept development; creating weekly task list for ten technicians, supervising test execution, providing technical support and problem resolution when required.

Inverness, United Kingdom

Creation, validation and verification of a method for determining moisture level within returned product to establish root cause following six sigma DMADV methodology.Resolution of product complaint investigations determining root cause, recording details in complaint database, reporting trends and ownership of CAPA actions.Critical understanding of Quality System Regulation (QSR), cGxP, Design Control and Process Validation guidelines, ISO, Risk Management, Design Control and Regulatory procedures.Designed, developed and delivered a life sciences modern apprenticeship program; successfully guiding four candidates through the process and establishing them in the workplace.Experienced in the validation of test methods, laboratory equipment and computer software applications including spreadsheets ensuring regulatory compliance.✔ 21 CFR Part 11 Electronic Records; Signatures✔ 21 CFR Part 820 Quality System Regulation✔ ISO 13485 Quality management systems✔ ISO 14971 Application of risk management to medical devices✔ ISO 15197 In vitro diagnostic test systems

Inverness, United Kingdom

Experienced in a wide range of laboratory equipment and analysis techniques; 2D/3D surface metrology, differential scanning calorimetry (DSC), rheological test methods, FTIR and FTIR-ATR analysis, confocal/optical microscopy and thermogravimetric analysis (TGA/EGA).Off site clinical studies, working with patients and healthcare professionals on clinical trials, home use and user accuracy studies across various projects and sites.

Inverness, United Kingdom

Quality assurance inspection; focus on reliable and repeatable measurements and precise data collection and entry.Experience of universal precautions and blood manipulation techniques.

Iraq

Served in Basra, Iraq as part of a force protection company, duties included; area domination patrols, base security activities and hearts and minds operations. A wholly life changing, fulfilling and positive experience!

Muir Of Ord, United Kingdom

Environmental, health and safety advisor for laboratory, conducting risk assessments and weekly audits.Routine quality control testing and approval of product prior to release.

Bachelor Of Science (Bs), Natural Sciences

Pda Certificate, Assessor A1