Randy Foster

Randy Foster

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  • Timeline

  • About me

    Quality Assurance Manager-NC/CAPA at Stryker

  • Education

    • Western Michigan University

      1981 - 1985
      Bachelor of Business Administration (B.B.A.) Major: Management Minors: General Business and Communications Arts and Sciences
  • Experience

    • Rite Aid Corporation

      Apr 1986 - Jan 1987

      Daily bank deposits, daily/weekly records of inventory flow, delegation of work duties, employee work schedules and general appearance and maintenance of store. Planned employee work schedules, maintained employee/customer relations, opened and closed store and ordered inventory.

      • Manager

        Nov 1986 - Jan 1987
      • Assistant Manager

        Apr 1986 - Nov 1986
    • Upjohn Healthcare Services

      Jan 1987 - Nov 1988
      Production Coordinator

      Interviewed, hired and oriented new employees, scheduled employees for work, monitored work performance and performed counseling, promotion and termination of employees.

    • Kirsch Company

      Nov 1988 - Apr 1994
      Production Supervisor

      Scheduled department supervisors and employees as well as directing daily line activities. Additional responsibilities included: Meeting department productivity requirements, employee performance evaluations, counseling of employees and implementing company policies and procedures.

    • Stryker

      Apr 1994 - now

      Stryker Medical's Division Process Owner (D.P.O.) Create an effective, efficient and compliant NC/CAPA process by supporting the Divisional NC/CAPA business, collaborating with other Stryker divisions to drive improvements to the eCAPA system and the NC/CAPA process. Driving day to day NC/CAPA activities in the Division, while ensuring all Corporate procedures are met as well as all external requirements. Created a compliant, smart and eficient complaint handling process. Balanced service report reviews, complaint investigations and MDR decisions into one lean operation. Responsible for the Divisions NC/CAPA program. Responsible for both the Incoming Inspection and Final Inspection teams. Achieved 100% Fixture Certifications, 100% Gage Calibration, and 99.9% same day service for Incoming Inspection. Lead the Incoming Inspection team to drive improvements and to provide inspection and metrology support for all Business Units. Achieved 100% Fixture Certifications, 100% Gage Certifications and 99.9% same day service for Incoming Inspection. Responsible for all team performance (132 assemblers) in the areas of safety, quality, delivery and performance to budget, team building, employee engagement, new product implementation, capacity and production planning. Adhere to quality and quantity standards and follow guidelines to meet product specifications. Provide training and mentorship to the Associate Team Leaders and Team Leaders. Responsible for all team performance in the areas of safety, quality, delivery and performance to budget, team building and employee engagement. The following are a list of teams that I have been responsible for: Second/Third Shift Production (1995), Med Surg Fabrication (1996-1997), Core Fabrication (1998-2000), Base Fabrication (2001), Speciality Assembly (2002), Core Assembly (2003-2005). Promoted to Senior Team Leader in February 2005. Responsible for all Assembly Team performance in safety, quality, on-time delivery to the customer and writing employee performance reviews.

      • Quality Assurance Manager-NC/CAPA

        Jan 2013 - now
      • Quality Assurance Manager - Post Market

        Feb 2011 - Jan 2013
      • Quality Assurance Manager - Inspection

        Jan 2010 - Feb 2011
      • Senior Quality Team Leader - Incoming Inspection

        Dec 2008 - Jan 2010
      • Senior Team Leader - Med Surg Assembly

        Feb 2005 - Dec 2008
      • Team Leader

        Apr 1995 - Feb 2005
      • Production Supervisor

        Apr 1994 - Apr 1995
  • Licenses & Certifications

    • Canadian Medical Device Regulations Auditor Course

      Canadian Medical Device Regulations SOR/98-282 & Canadian Medical Device Conformity Assessment System (CMDCAS)
      Nov 2016
    • Quality Management System Lead Auditor (ISO 9001:2015), inclusive of ISO 13485:2003 and ISO 13485:2016

      Exemplar Global (Oriel STAT A MATRIX)
      Jul 2016
      View certificate certificate
    • Master's Certificate in Project Management

      The George Washington University
      Aug 2015
    • Regulatory Affairs Certificate: Medical Devices

      Regulatory Affairs Professionals Society (RAPS) Online University
      Sept 2012
    • Gallup Support Services Perceiver Specialist

      The Gallup Organization (Certificate No. 056)
      Jun 2000
    • ECAPA Train the Trainers Program

      Stryker
      Sept 2012
  • Honors & Awards

    • Awarded to Randy Foster
      Fire Starter Award for NC/CAPA Stryker Apr 2013
    • Awarded to Randy Foster
      Gallup University Great Manager Program - Dec 2004
    • Awarded to Randy Foster
      Stryker Medical Performance Excellence Award - Dec 2004
    • Awarded to Randy Foster
      Stryker Medical Team Leader Excellence Award - Dec 2002