Experience

• 

  Lower kuskokwim school district

  Aug 2002 - Aug 2003

  Fifth and sixth grade teacher
• 

  Tomotherapy

  Jun 2004 - Jun 2011

  Senior document control coordinator

  The Senior Document Control Coordinator is responsible for the review, approval, logging, and storing of controlled documents and records. The records include quality system as well as product specific documents. The position holder will utilize various record retention tools and databases and will interface with virtually all levels of personnel within the company.In addition, this position is the administrator of the Oracle Agile system.

• 

  Accuray

  Jun 2011 - May 2015

  Document control specialist iv & agile administrator

  TomoTherapy was acquired by Accuray. The Senior Document Control Coordinator is responsible for the review, approval, logging, and storing of controlled documents and records. The records include quality system as well as product specific documents. The position holder will utilize various record retention tools and databases and will interface with virtually all levels of personnel within the company.Agile Administrator role began December 2013.

• 

  Philips

  May 2015 - Oct 2023

  • Led a team of fifteen (15) employees covering quality management system (QMS) topics of: document change management, product change management, non-product software administration, record control, management review, audit, training and various quality activities.• Directly responsible for oversight and management of local quality management system compliance and alignment with enterprise framework, management review, quality planning, quality metrics, intra-company quality agreements and other quality activities.• Maintain continued Quality System Certification by leading internal and regulatory agency audits; including coordinating with regulatory and certifying bodies, and conducting internal and external audits. Among others, this included 21 CFR 803, 806 and 820, CE mark, MDSAP and ISO 13485 and EU MDR standards.• Led large scale projects: quality project with over 150 stakeholders to successfully close a site, transfer the product responsibility and deregister the quality management system within 3 months. Most recently, drove project to separate a multi-modality site in another country into two quality management systems, register the site and progress towards certification. Show less • Deliver high value risk assessments of compliance, strategic or business risks of Philips. Work with all levels of the organization to identify and align stakeholders on mitigation of risk. • Facilitate risk workshops establishing risk profiles for clusters, businesses and functions. • Maintain detailed 6-month scheduling plan and project organization in alignment with auditees and team members for 3-6 audits/workshops simultaneously.• Work creatively and analytically in a problem-solving environment as well as think through complex challenges and deliver results.• Actively provide peer feedback and coaching to colleagues throughout audit engagements and additionally when subject matter expertise is required.• Change Champion for multiple department AIPs – Talent/People (2019) and Processing Mining (2020). Show less I'm the department manager for a three-branch team - areas covered are Quality Management Systems Documents, Product-Related Change Management and Quality Record Archiving. When I joined Philips, I took on the challenge of a created role and team merged from 3 departments. Right-sized, standardized and streamlined processes and team including creation of a QMS navigation system, department FAQs SharePoint and quality review checklists with detailed error analysis. I have led that team to complete a site record consolidation project of over 150,000 records dating back to 1932 while supporting other interdepartmental projects. We have improved the QMS change order throughput by 61% (102 to 40 days) in a six sigma project. I have run internal and third party audit backrooms for more than 6 months – as well as traveled internationally to provide training on this role. I am currently acting as Site Representative on the Agile (Software System) Global Foundation Team and led my local team to support global system validation. We have had zero functional area findings or observances during FDA inspection since my arrival. I was also asked to represent Philips in a Quality Gene recruitment video and have gotten the opportunity to participate in multiple Kaizen events. Show less

  • Head of Philips Quality Management (PQMS), Hospital Ventilation

    Sept 2021 - Oct 2023

  • Senior Audit Manager

    Jan 2019 - Sept 2021

  • Document Control Manager

    May 2015 - Jan 2019
• 

  Medtronic diabetes

  Nov 2023 - now

  Senior quality systems manager