’s-Hertogenbosch, North Brabant, Netherlands
Allow me to give a short introduction/summary of who I am? Expert in GxP/cGMP, ISO13485, ISO14971, ISO14155, ISO 19011, EN60601-1/-2-xxx, 21CFR Parts 4, 11, 820 , ISO17025 and ISO15189. "MY PASSION IS QUALITY", meaning .... that I can, and shall use all my competences and skills as gained through the many years of having worked for various Healthcare Organizations, from Start-up's ... to the already (for many decades Global) established ones like GE, J&J, Philips and Novartis, in implementing and supporting "a balanced Quality Awareness and Attitude culture". By considering the to be realized objectives as set for BOTH ..., - the BUSINESS itself; maintaining a sustainable organization, satisfying its financiers, generating sufficient profit, developing and manufacturing great products, safe and reliable, having sufficient resources, AND ..., - the PATIENTS(/end-user), receiving safe and reliable products which will support their health, .. by satisfying the more and more demanding needs for excellent Healthcare products, and ... to support the increasing call for the best possible quality of life of those Patients. Having worked myself up, from ....... work-floor level up to the various Managerial/functional levels I did fulfill successfully, and by the more than 13 years of additional evening- and weekend studies after starting my working career, I do believe that the best way of accomplishing things is by explaining "the reason(s) behind!" rather than ordering "because they say so". Also, consider ... that many rules & regulations DO MAKE SENSE!
As a Systems Quality Management Expert, I shall be responsible for setting, refining, and upholding quality standards across the business. This role is deemed crucial in ensuring customer satisfaction and effectively managing complaints, while also overseeing safety and compliance. In addition to the internal focus, another key role shall be, collaborating with our suppliers. Working closely with them on New Project Developments, Life Cycle Management, and continuous improvement initiatives. Maintaining strong supplier management as essential to introduce and sustain high-quality standards. Being the gatekeeper of quality for the market and hold significant influence in project decision-making. Working together with the Quality & Standards team for the business group- Professional, reporting to the Q&S Manager. This team consist of 4 people. Being based in The Netherlands, working in project teams with co-ordination with marketing teams, manufacturing teams at various sites, supplier teams, and other team members across FrieslandCampina.
As Lead Auditor ISO13485:2016 to conduct (Supplier) Quality Management System Audits as based on ISO13485 and 21CFR Part 820
Consultant and Auditor (ISO9001, ISO13485 / 21CFR820, 21CFR4 and ISO17025) support, by using more then 25 years of experience in the Product and System Quality (and Regulatory) international world, to help organizations showing the added values of a good Quality System, being able (by GAP-analysis through assessment) finding bottlenecks, initiate/coordinate/implement improvements, generating a good fundament for Quality Awareness and Attitude by overall involvement and training from top to bottom.
Finalized the GAP analysis for the upcoming CE/ISO13485 and MDSAP - recertification Audit and given recommendations towards its compliancy level.