Carl Willkom Email & Phone Number

Saint Paul, Mn, Us

Humlebæk, Denmark, Dk

Humlebæk, Denmark, Dk

-Providing technical support with the development of products in compliance with design controls, international standards, and FDA and other regulatory body guidance’s.-Creating and maintaining Design History Files, and updating legacy files to meet new regulation. -Performing and managing the product stability program to ensure all products have adequate heat-age and real-time aging for support of shelf life. -Managing the Risk Management process; including conducting product and process risk assessments as well as redefining the overall Risk Management Process. -Managing statistical support for test method validations and sample size requirements.-Working with cross-functional teams to complete the implementation of design transfer.-Performing standards review for all relevant processes (ISO 13485, 14971, etc.)-Providing cross-functional support to internal teams and external physicians.

Minneapolis, Mn, Us

-Managed 3 Quality Inspectors and a Calibration Technician. Provided plans and managed activities concerned with the workflow of the Quality Inspection group. -Coordinated and oversaw all cleanroom certification activities for ISO Class 7 and Class 8 cleanrooms.-Designed and executed product assurance programs to effectively develop and approve new products to meet the requirements of customers.-Prepared, reviewed and analyzed design history documents to assure technical accuracy, completeness, and compliance with applicable internal, regulatory, and customer guidelines.-Prepared validations, verifications, risk analysis documents, and other product assurance activities.-Provide quality engineering support for pilot, pre-production and production lines.

Wilmington, Massachusetts, Us

Initially hired as the Calibration Engineer, I: -Managed 3 Calibration Technicians, planning and coordinating the control and calibration for all Chaska Facilities. -Recommended and coordinated purchase of new and replacement measurement equipment. -Performed Gage R&R's and analysis for products and test methods-Improved efficiency and accuracy of the current standard operating procedures and quality measurement systemsIn 2015, I was then asked to apply internally for a Design Assurance position, where I: -Designed and executed product assurance programs to effectively develop and approve new products-Prepared, reviewed and analyzed design history documents to assure technical accuracy, completeness, and compliance with applicable internal, regulatory, and customer guidelines. Ensure accurate and complete design records are maintained. -Prepared validations, verifications, risk analysis documents, and other product assurance activities.-Developed and validated new test methods and measurement equipment. -Provided quality engineering support for pilot, pre-production and production lines. -Ensured test methods are in place to meet design specifications, customer requirement specifications, and any required standards.

Wilmington, Massachusetts, Us

- Provide programming expertise for automated measurement systems- Perform Gage R&R's and analysis for products and test methods- Improve efficiency and accuracy of the current standard operating proceduresand quality measurement systems

St. Paul, Minnesota, Us

Working in Corporate Foundation Relations taking care of paperwork for the donations to the University of St. Thomas.

St. Paul, Minnesota, Us

Assigned to 6th floor and was responsible, with the other residence hall staff, for fostering a cooperative and considerate community environment which contributes to the academic and personal growth and success of each resident.

St. Paul, Minnesota, Us

Chosen as one of 12 students to represent the University. Had to lead new freshman throughout their orientation day, as well as give presentations to them on University Policies, expectations, and opportunities. Worked 10 to 12 hour days learning time management skills, and team building skills.

Vadnais Heights, Mn, Us

Individually tasked with the development of training tools for service workers in the field during the course of a summer internship under the supervision of a Technical Service and a Marketing representative. - Assist in new project development and planning- Process and project documentation- Work cross functionally with the technical teams and the marketing teams- Present to corporate VP's at the completion of the project

Worked with a team of three workers to analyze and critique truss orders, and then to constructthe order in given time frame. Learned innovative problem-solving techniques, and time management skills.

Master Of Business Administration - Mba

Bachelor Of Engineering (B.E.), Mechanical Engineering

Education record