Peter Michiels Email & Phone Number

Amsterdam, Noord-Holland, Nl

Lead and manage the safety complaint handling processes for Philips' personal health products, ensuring regulatory compliance and consumer safety. Interacting with consumers and regulatory authorities on product safety complaints or recalls, collaborating with cross-functional teams to resolve safety complaints and mitigate product risks, ensuring effectiveness and efficiency of safety processes and managing their governance across the business.Applying expertise in device design, product risk management, clinical effects, and safety to effectively conduct safety surveillance, and monitor safety signals, analyze and interpret safety data to identify potential risks.Advocating for consumer rights by representing their interests in the handling of potential safety complaints.Leveraging Quality & Regulatory expertise in both the medical device and consumer product industries to effectively and efficiently use the outputs of Complaint Handling processes as essential inputs for continuous improvement and the delivery of safe, reliable products. The ultimate goal is to make a meaningful impact on Consumer Satisfaction ("Delight Customers") and Product Safety and Quality.

Eindhoven, Brabant, Nl

Providing leadership and hands-on quality and regulatory consulting for customer, enabling timely clinical evidence to launch safe and effective, as well as their best product(s) to the market to improve lives.The approach taken, focuses on the "de-risking" of applicable business processes and/or technology, whilst balancing regulation, compliance, resources and innovation. Expertise is leveraged at various stages throughout the product development process to ensure compliance every step of the way, from research and development through manufacturing, marketing, and final approval.In addition, enabling/realizing positive regulatory impacts and set the customer's organization up for greater success by using a customized and business-balanced approach to optimize quality systems, capitalizing on best and proven practices whilst using the EU MDR [EU 2017/745], FDA QSR [21 CFR Part 820], and other relevant and applicable industry-leading standards and regulations as backbone for regulatory maturity assessments. Reviews a wide range of documentation to ensure adherence to good documentation practices and QMS compliance. Supports in CAPA resolutions, predominantly from a regulatory perspective.Achievement Examples:1/ Prepared the Regulatory Strategy and Plan for a new range of electric breast pumps for lactating women.2/ Supports all Regulatory activities in the development and US-release of a women’s health pregnancy support app.3/ Supported the internal Philips Product Quality Remediation Plan.4/ Developed a training/course for the Systems Engineering curriculum: “Systems Engineering in a Regulated Environment – Medical Device Design & Development”.

Veldhoven, Nl

As Department MT-member, responsible to provide leadership for the development and execution of the Quality and Operational Excellence strategy and roadmap for the Opto-Mechanics department within Development and Engineering (D&E), aligned with the broader strategies of D&E.Drive/support efforts to structurally improve ASML’s Product Generation Processes and promote transparency, standardization and simplification whilst securing process adherence.Ensure that all products to be released comply with all relevant applicable standards and regulations by implementing requirements, conditions, and enablers in the standard Product Generation Process by capitalizing on the added value of end-to-end risk-based thinking and implement the lessons learned from various feedback loops. Supported Design Transfers to Manufacturing.Achievement Examples:1/ Designed and implemented a KPI Dashboard (vital few KPIs) as basis for performance measurement and the department’s continuous improvement program.2/ Revitalized the Design Review process within own department to be leveraged across the rest of D&E.

Eindhoven, Brabant, Nl

Responsible for developing and strengthening the management systems and business processes to improve performance and create value for stakeholders in accordance with our strategy, policy, and applicable regulatory requirements. The end game is about achieving excellence in everything that Philips Innovation Services does [including leadership, strategy, customer focus, information management, people, and processes] and, most importantly, achieving superior business results to continually strengthen our role as service provider and supplier to third parties, including medical device manufacturers.Achievement Examples:1/ Designed and implemented a new system architecture to optimize the Quality Management System (QMS -- named MSIS: Management System of Innovation Systems) to be compliant with ISO 13485:2016, while improving its ease of use (User Interface).2/ Managed all aspects of the development, optimization, and deployment of a new QMS for the Philips Innovation Services business reporting to the MT. 3/ Oversaw subsequent development and continuous improvement of the QMS in compliance with applicable and relevant standards and regulations.

Eindhoven, Nl

Proactively developed, led and drove execution of global quality assurance (QA), and regulatory and clinical affairs (RACA) with a focus on efficient, rapid, and timely approval of robot assisted surgical devices. Overall responsibility for the development and implementation of the Quality Management System (QMS), including the setting of quality goals, managing, and improving all aspects of product quality and reliability with an emphasis on customer use and expectations. Directed the development of systems, practices, and processes to ensure efficient and effective clinical investigations including clinical investigation management, data analysis, final study report and publication. Heavily involved – as member of the MT – in developing, implementing, and shaping the company’s strategy (“vital few objectives”) and drove translation of strategic/business ambitions into tangible goals and Quality objectives, both at the company level and drilled down to individual direct report annual objective and goal setting level.Achievement examples:1/ Designed and implemented a QMS compliant with ISO 13485:2016 and in accordance with Annex II or V of MDD 93/42/ECC, and US FDA 21 CFR Part 820.2/ Led the CE marking process and the FDA approval process of the PRECEYES Surgical System.3/ Contributed to the first (successful) human clinical trial at Oxford University in June 2017 to perform the first robot-assisted vitreo-retinal procedure with the PRECEYES Surgical System to demonstrate safety and efficacy (dissection of the epi-retinal membrane and inner limiting membrane over the macula).

Waterloo, On, Ca

Led a team of Quality & Reliability Professionals and Quality Controllers. Accountable for the governance of the development and implementation of all aspects of the Quality Management System (QMS), Regulatory Affairs, product quality and product reliability by establishing effective quality systems, product and process design qualification strategies, and procedures and implement them during product design, development, validation, production and after sales support. Set the vision of QMS development aligned with the company’s strategic business goals and (envisioned) organizational growth. Ensured that Quality Engineering, Quality Control and Quality Assurance were solidly embedded in the company’s Product Creation Process, Supply Chain Management, and (other) ongoing operational processes.Achievement Examples:1/ Introduced ‘Regulatory Affairs’ management as a new ‘discipline’ within the Quality Department.2/ Revitalized the QMS to ensure compliance with the requirements of 21CFR820 (FDA QSR − Quality System Regulation).3/ Ensured compliance with the requirements of IEC 60601-1, 2nd, and 3rd editions and the MDD (93/42/EEC) to appropriately certify our products prior to market entry.4/ Supported projects to resolve quality issues on time, both internally and related to issues associated to quality inspections of incoming and outgoing materials and products.

Amsterdam, Noord-Holland, Nl

Managed a team of senior professionals to lead and direct strategic business process improvement in Sales and Operations to achieve greater business efficiency and throughput, as well as continuous improvement initiatives to improve quality and reliability, operations processes and overall operational effectiveness and efficiency. Led the execution of the Business Management System (BMS), integrating strategy planning and deployment (Hoshin Kanri), scorecard management, and business reviews to deliver an improving and predictable business.Designed the Business Excellence program content, deployment, approach, and tools. Managed the Business Excellence Managers (dotted line) in our 13 Key Markets. Achievement Examples: 1/ Designed and built an organization from scratch that became responsible for improvements over 100M€ in sales one year after creation.2/ Developed and implemented a project portfolio management process to prioritize, link, and assign 100 projects across 60 geographies. 3/ Deployed the Philips Business Excellence (PBE, identical to EFQM) model across the key markets in the Global Sales and Service organization.4/ Introduced the focus on Process Excellence leading to significant efficiency improvements.

Amsterdam, Noord-Holland, Nl

Developed, implemented and managed a Business Excellence and Quality program; working in concert with the Program Management Team to provide the leadership that drove business excellence; Managed improvement projects/initiatives and the redesign of processes for implementation of business excellence in every area of the research Program organization; Served as internal consultant to the management teams to coach and provide direction with regard to Philips Business Excellence (PBE, identical with the EFQM model); Implemented and managed the appropriate procedures, regulations and guidelines related to managing “Environmental, Health and Safety [EH&S]”. Acted as Secretary to the Research Program Management Team.Achievement Examples:1/ Implemented the use of “One-Page Strategy” (OPS) methodology, integrating strategy development, deployment, and translation in annual key initiatives.2/ Developed and maintained key performance indicators (KPI) dashboard and balanced scorecards.3/ Implemented appropriate Environmental, Health and Safety procedures, regulations, and guidelines.4/ Provided structure and tools and techniques to Research Project Leaders.

Amsterdam, Noord-Holland, Nl

Responsible for Design Quality Management within the Business Line Optical Pickup Units (OPU) and managing a team of Quality & Reliability Engineers (same as below). Responsible for Total Quality Management within Product Line DVD. Due to a change in organizational structure to increase product focus, the business line was organized into three Product Lines [DVD, RW and ROM]. Each product line was organized as a “mini company” with its own product development, industrialization, and quality management. I was asked to assume the role of Total Quality Manager of the Product Line DVD whilst keeping the overall responsibility of managing Design Quality for the entire Business Line. The Product Line DVD was based in Eindhoven whilst the Business Line was headquartered in Hasselt, Belgium. That enabled me to develop multi-site management skills.Achievement Examples:1/ Introduced and maintained an efficient process-oriented way of working within the Product Line DVD and OPU Eindhoven Site.2/ Implementation of ISO 9000 Quality Management standard and ISO 14001 Environmental Management System for OPU Eindhoven Site.3/ Supported the 'translation' of System Requirements into appropriate Verification and Validation Programs.4/ Ensured testability of requirement working with Quality Engineers.5/ Ensured the proper introduction and use of statistical methods and techniques to analyse measurement data and its post-processing.

Amsterdam, Noord-Holland, Nl

Responsible for Design Quality Management within the Business Line, managing a group of talented Quality and Reliability Engineers. Provided sufficient resources in various project teams for New Product Introductions to fully secure all (design) quality and reliability aspects; ensuring qualification and release of new components and proper technical documentation by Development; ensured the release of new products and processes by means of evidence-based Reliability Test Strategies, Design Verification Test Programs; facilitated FMEAs, used maturity grids and Design of Experiments; ensured good interaction with Operations & Customer Quality on ongoing reliability, customer complaints and industrialization/manufacturing quality to integrate improvement opportunities in development phase of new products and processes; managed department’s capital investments and organizational costs; coached and nurtured team members on technical competences and provided requisite training; organized regular departmental information meetings to share relevant business information; staff selection and recruitment; conducted performance appraisals and reviewed individual employee performance.Achievement Examples:1/ Established a motivated team of Quality and Reliability engineers, all allocated to various product development projects as responsible Quality & Reliability Engineers owning all Quality Engineering roles and responsibilities.2/ Coached my team of Quality Professionals in a learning organization focusing on their own career development.3/ Developed and implemented “evidence based” (based on ‘physics of failure’) Reliability HALT test program and associated Design Verification Test protocols/systems (collaboration effort with the University of Hasselt, Belgium).

Amsterdam, Noord-Holland, Nl

Given my growing interest to combine a technical function with a more ‘customer-facing function’ I was given the opportunity to join the Sales Office of Philips Electron Optics in Belgium. My main roles and responsibilities included installing, maintaining, and repairing (scanning) electron microscopes, liaising between Philips Electron Optics Belgium and the Electron Optics International Business Centre, Eindhoven (the Netherlands), giving product user trainings at customer’s site, providing quality service (both product and application related) to the customers. Our main customers were Universities, Hospitals and Research Centers in Belgium. This provided me with the opportunity to build and maintain many customer relationships within a diverse base of customers thereby ensuring the targeted customer satisfaction levels.

Amsterdam, Noord-Holland, Nl

For the development of CD-Recorder (CD-R)/ReWritable (CD-RW) and CD-Interactive (CD-I) decoding electronics, there was an apparent need of analog electronics competencies that I possessed [for the largest part due to my personal interest in that specific area of electronics]. My main roles and responsibilities covered the whole path from developing the decoder electronics [specifically analog PLL circuits], assessment of primary product concepts in co-operation with Pre-Development to the validation of designs in customer products. This also entailed verification and validation of designs in customer projects and factory release procedures, sharing project responsibility within a multi-disciplinary team with multiple links to other parts of the organization including customer interface and Manufacturing. By doing so, a timely introduction of Philips’ first CD-Recorder in the market was ensured with low Field Call Rate (FCR) figures.

Evere, Be

Taught analog electronics [Electronic Circuits and Pulse Wave Generators], Electronic Measurement Technology, Telecommunication, and Elementary Mathematics (secondary technical school level). Compiled course syllabuses about Operational Amplifiers (OPAMPS), Analog Filters, Electronic Measurement Technology, Complex Numbers, and Basics of Linear Algebra [for continued use after my departure].

Medicine

Business & Management Science

Msc, Electrical And Electronics Engineering

Pre-University Education Degree, Mathematics & Science ["Wetenschappelijke A", Comparable With Dutch "Vwo"]