Diane Baker Email and Phone Number
Diane Baker work email
- Valid
- Valid
- Valid
Diane Baker personal email
An enthusiastic senior professional who combines a strong technical background in new product development with a proven track record of success in Quality, Operations and Commercial leadership. Keen to use extensive experience to add value to the Medical Device Industry, including material suppliers and service providers, in a rapidly-changing regulatory environment. Committed to customer satisfaction and continuous improvement, through collaboration and building productive relationships, while challenging the status quo. Develops dynamic project teams by enlisting the right people from across relevant functions to drive effective implementation of initiatives, maintaining a disciplined approach to risk and change management, and aligning with business strategies. Provides clear direction by setting realistic but aggressive goals, supporting individuals with ongoing training and recognition.
Convatec
View- Website:
- convatec.com
- Employees:
- 6617
-
Senior Director, Quality, Regulatory And Clinical AffairsConvatecEllesmere, Gb
-
Career TransitionCareer Break Aug 2023 - Present
-
Senior Director, Quality, Regulatory And Clinical AffairsConvatec Aug 2019 - Aug 2023London, England, Gb
-
Technical And Quality SpecialistIndependent Consultant - Medical Devices Mar 2018 - Aug 2019CORE COMPETENCIESCompliance expertise:o BS EN ISO 13485:2016 o BS EN ISO 14971:2012o BS EN 17025:2017 o FDA 21 CFR Part 820o FDA 21 CFR Parts 210 and 211o MDD 93/42/EEC o MDR 2017/745 Medical device technical expertise:o Orthopaedic / dental o Wound careo Continence careo Drug elutiono Infection controlo Polymer science o Coatings for medical deviceso Medical Device packagingKey Skills:o New Product Development and Design Controlo Validation o Six-sigma green belt o Risk Management including FMEAo Practical problem solving and Root Cause Analysiso Strategic Business Planning and P&L Managemento Project Management
-
Senior Quality Manager, UkAdvanced Medical Solutions Apr 2016 - Feb 2018Winsford, Cheshire, Gb• Site representative over two UK sites• Successful first time FDA inspections at both sites• Certification to BS EN ISO 13485:2016 at both sites• Defined schedule for transition to Medical Device Single audit Program (MDSAP)• Planned QMS improvements to support compliance with Medical Device Regulation MDR 2017/745• Restructured UK Quality team to improve efficiency and enable personal development of individuals -
Commercial DirectorSmithers Rapra And Smithers Pira Ltd. Jan 2009 - Mar 2016Shrewsbury, Shropshire, Gb• 20% year-on-year sales growth• Doubled sales into medical sector over previous three years by understanding specific customer requirements and aligning service offerings to satisfy these demands• Directing a team of Business Development Managers, Marketing Manager and Sales Operations staff• Executed a disciplined proactive sales plan, setting aggressive client contact and prospecting targets to deliver opportunity funnel growth of 120% over the last three years• Devised and implemented a sales process for effective management of opportunities and customer contact, to put the satisfaction of our customers at the heart of our business• Developed tools for opportunity assessment and strategic account management -
Director Of Quality And TestingSmithers Rapra And Smithers Pira Ltd. Jan 2008 - Jan 2009Shrewsbury, Shropshire, Gb• Full P&L responsibility for 3 business units over 2 UK sites• Revenue growth of 40% and six-fold increased EBIT on 2007 results• Planned and implemented organizational restructure in the laboratories to support strategic objectives and improve profitability• Recruited to support new structure and set goals and objectives in line with company KPIs• Achieved group UKAS accreditation for Testing facilities at both UK sites, saving costs of maintaining separate accreditations
-
Quality ManagerSmithers Rapra And Smithers Pira Ltd. Feb 2007 - Jan 2008Shrewsbury, Shropshire, Gb• Designed a comprehensive Quality Management System and directed the implementation over 2 UK sites• Worked as a member of the senior leadership team during annual Ops Planning to align Quality strategies and define business-driven efficiency improvement projects• Maintained ISO 17025:2005 accreditation – 2 testing laboratory certificates and calibration certificate• Developed clear subsystems for compliance with additional quality requirements, such as GMP, in line with customer requirements• Accountable for budget control for Quality and Calibration departments, reducing costs by eliminating reliance on outsourced resources• Devised customer-focused Quality metrics, and implemented a CAPA system for measurable continuous improvement
-
New Product Development Project ManagerDepuy Synthes Companies Jan 2000 - Jan 2007Raynham, Ma, Us• Managed cross-functional Project Teams to deliver new product development projects from concept to launch• Six Sigma Green Belt in Process Excellence/Design Excellence and applying DoE techniques• Updated global SOP for Design Control, to satisfy the combined requirements of both ISO 13485 and FDA CFR 21 Part 820, conducting annual training sessions for relevant staff• Independent reviewer for all stage-gate and Design Reviews• Risk planning and management in compliance with ISO14971• Superuser for the DePuy Product Actualisation and Commercialisation stage-gate process• Qualified auditor• Managing relationships with surgeons, external consultants and university partners, agreeing proposals and budgets• Technical leader in acrylic polymer chemistry, curing and coating technologies, and the development of porous ceramics for orthopaedic medical device applications. Patents filed for the following: o Bioactive bone cement formulation o Acrylic hydrogels for drug-delivery coatings o Geometric cartilage repair devices -
Research FellowBrunel University London Jan 1997 - Jan 2000Uxbridge, Middlesex, Gb• Conducted EPSRC-funded project on surface analysis and modification of urinary catheters• Designed a clinical study performed at Southmead Hospital, Bristol• Delivered lecture modules on Biomaterials for the Special Engineering Program• Supervised projects of PhD students, MEng students and final year undergraduates
Diane Baker Skills
Diane Baker Education Details
-
University Of DundeePolymer Chemistry
Frequently Asked Questions about Diane Baker
What company does Diane Baker work for?
Diane Baker works for Convatec
What is Diane Baker's role at the current company?
Diane Baker's current role is Senior Director, Quality, Regulatory and Clinical Affairs.
What is Diane Baker's email address?
Diane Baker's email address is di****@****pra.com
What schools did Diane Baker attend?
Diane Baker attended University Of Dundee.
What skills is Diane Baker known for?
Diane Baker has skills like Plastics, Product Development, New Business Development, Polymers, Business Strategy, Continuous Improvement, Materials, Manufacturing, R&d, Project Management, Injection Molding, Process Improvement.
Free Chrome Extension
Find emails, phones & company data instantly
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial