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Frederic William Beck

My skills and experience for mutual success

Elevator pitch

I bring more than twenty years of experience in various aspects of quality management of GxP regulated medical device and in-vitro diagnostic product manufacturing & development, as well as the machinery manufacturing industries of passenger rail vehicles, photovoltaic module manufacturing, and packaging equipment for pharmaceutical and medical products.

I am passionate about the continuous improvement of collaboration and communication, in teams as well as company-wide, and about the development, implementation and maintenance of appropriate, modern tools and resources for this purpose.

I like to solve problems with my analytical thinking skills, coupled with logic, systematic and rationality. I am goal and performance-oriented, able to work under pressure and work independently.

I am an open-minded person, a team player, thorough, loyal, with integrity, and fluent in English and German.

Skills

10
Medical & pharma industry experience

11 years of experience with planning, implementation and documentation of risk-based GxP qualification concepts

7
Qualification & validation experience

7 years of experience in qualification & validation of production equipment and processes for medical devices and IVD consumables

3
Pharma packaging industry experience

3 years of experience in the qualification of pharmaceutical packaging equipment according to GAMP

10
Quality management experience

19 years of experience in various disciplines of quality management

10
English and German language knowledge

German and English mother tongue, business fluent spoken and written

9
Technical insight

Technically and mathematically savvy, expertise and creativity in developing and using computer-based productivity tools.

Work experience

Mar 2024current

Manufacturing Engineer

Becton, Dickinson and Company · Wangs SG
  • Manage a project to significantly cut the component cost by shifting from CNC machining to injection molding
  • Develop and execute process validations and performed periodic assessment of validated state for internal and external processes
  • Contributed to cost and waste reduction through kaizen initiatives, in particular related to cleanroom drying time after washing/disinfection
Oct 2022Feb 2024

Quality Engineer, New Product Development

Becton, Dickinson and Company · Wangs SG
  • Developed a standard operating procedure and training for incoming inspection and batch release sampling plans
  • Developed and executed equipment qualifications and test method validations for various measurement equipment and inspection methods
  • Provided quality support for acceptance testing of assembly and measurement equipment
  • Supported document reviews and approvals and customer complaint investigations and recordkeeping
Feb 2018Jul 2022

Senior Quality Planner

Weidmann Medical Technology · Bad Ragaz SG
  • Planning of qualification tasks for the team in cooperation with the technical departments and project management
  • Calculation of qualification costs for new projects and changes
  • Development of qualification concepts based on project specifications and normative, regulatory requirements
  • Execution of own qualification work, measurements, assessments for the projects in implementation including preparation of reports
  • Conceptual and technical support of coworkers through qualifications
  • Development of new measurement methods and validation strategies
  • Performing risk analysis and FMEA
  • Technical support in change management
  • Conducting internal audits according to ISO 13485:2016 requirements
Sep 2017Jan 2018

  • Self-study French and Spanish
  • Lead team of 18 volunteers in association activities
  • Design and maintenance of website and other IT systems for association activities
Jul 2014Aug 2017

Validation, Safety & Quality Manager

Dividella · Grabs SG

Validation (~70%)

  • Developed validation documentation (FS functional specification, DS design specification, IQ installation qualification, OQ operation qualification) pursuant to FDA and EMA current good manufacturing practices (cGMP) and GAMP guidelines
  • Developed documentation for and participated in over 30 Factory Acceptance Tests (FAT) with customers

Occupational safety (~5%)

  • Conducted periodic and spontaneous safety audits
  • Enforced company occupational safety policies

Quality management (~25%)

  • Transitioned the existing quality management system to achieve ISO 9001:2015 certification already 18 months before due date
  • Facilitated process overhauls workshops (supply chain management, customer service, continuous improvement, sales)
Feb 2011Jun 2014

Quality Engineer

TEL Solar (formerly Oerlikon Solar) · Trübbach SG
  • Maintained and streamlined the failure reporting, analysis, and corrective action system (FRACAS) and provided new employee trainings and refresher courses
  • Implemented a process for monthly analysis and review of supplier on-time delivery (OTD) and participated in a task force to improve this KPI from as low as 60% to above corporate target of 99%; Solar team received corporate award for accomplishing this in shortest time
  • Documented and simplified the processes complaint management, supplier audit, and acceptance testing for the quality management system and introduced monthly key performance indicators (KPI) for management reporting
  • Defined and rolled out a new handling of non-conforming material process to meet an urgent business need
  • Filed and followed up on over 250 supplier quality and internal complaints and transport damage cases employing the 8D problem solving methodology and performed analyses of cost of poor quality (COPQ) for charge back negotiations
  • Signed off on several acceptance test procedures (ATP) as part of the internal review and release loop, and witnessed and signed off on initial (IAT) and final acceptance tests (FAT) at several suppliers
Feb 2008Feb 2011

Reliability Manager

Oerlikon Solar (later TEL Solar) · Trübbach SG
  • Established and maintained a web-based failure reporting, analysis and corrective action system (FRACAS) to efficiently respond to incidents by determining necessary actions within the organization and with suppliers
  • Provided FRACAS training and coaching to over 100 employees
  • Produced periodic reports on equipment uptime, yield, SEMI E10 machine operating status, and problem solving status
  • Coordinated cross-functionally with customer support, product development, customer project management and sourcing
  • Introduced web-based workflow tools for preventive maintenance planning and feedback and for defining, deploying and tracking equipment retrofits at multiple customer sites
Jul 2005Sep 2005

Intern Consulting Human Capital

Deloitte Consulting · Zurich ZH
  • Contributed to and leveraged global talent management survey
  • Amended and customized Deloitte talent management service offering and methodology to German and Swiss market requirements
  • Developed Swiss go-to-market strategy in coordination with global talent management teams
Nov 2002Aug 2004

Quality Assurance Test Engineer

Bombardier Transportation · Plattsburgh NY · USA
  • Developed and maintained test procedures and reports in accordance with customer specifications and ISO 9001
  • Designed, developed, deployed and continually updated equipment failure knowledge base
  • Provided troubleshooting guidance and training to test technicians
  • Assessed root causes for testing problems and delays and channeled corrective action to the source (production, engineering, supplier, quality assurance)
  • Performed engineering tests for design change proposals
  • Developed customized test routines for retrofit modifications
  • Designed and procured test equipment
  • Obtained and analyzed field service problem reports and established preventive measures
  • Presented periodic key performance indicators and improvement plans to management
Aug 2000Nov 2002

Electrical Test Technician

Bombardier Transportation · Plattsburgh NY · USA
  • Tested rail car equipment in accordance with its test procedures and specifications
  • Troubleshot and repaired rail car and test equipment
  • Field service support
  • Acceptance testing with railroad customer representative
Jul 1998Dec 1998

Intern Research and Development

Laser Diagnostic Technologies (now Carl Zeiss Meditec) · San Diego CA · USA
  • Conducted research on and participated in clinical trials of novel imaging techniques for scanning laser ophthalmology for early detection of common eye diseases
  • Improved and tested diagnostic laser equipment
  • Implemented new technologies into existing products

Education

Jan 2005Dec 2005

Master of Business Administration MBA-HSG

University of St. Gallen · St. Gallen SG

AACSB and EQUIS accredited one-year full-time MBA program

  • Electives pursued: international marketing, supply chain management, applied value-based management, business planning & entrepreneurship
  • Subjects: accounting & controlling, international management, organizational economics, marketing & communication, principles of finance, organizational behavior, business environment, financial markets, innovation & technology management, information management, strategy, business law
  • MBA project: Building a strategic talent management service offering for Deloitte Consulting in Switzerland and Germany
Sep 1996Dec 1999

Engineering Degree Dipl.-Ing. (FH)

University of Applied Sciences Technikum Wien · Vienna · Austria

Four-year electronic engineering university of applied sciences

  • Electives pursued: bio-medical engineering, computer sciences, Spanish
  • Subjects: telecommunications, data processing, industrial process measurement & control, mathematics, English, business administration, corporate governance, marketing, law, economics, project management, production planning, quality management, personality development, principles of electricla engineering, laboratory, workshop, design & assembly, electronics & digital technology
  • Graduation thesis: Multiply Scattered Light Imaging of the Human Retina with a Scanning Laser Ophthalmoscope, internship completed at Laser Diagnostic Technologies

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