Jamie E. Olsen's Location
Rochester, New York, United States, United States
Jamie E. Olsen's Contact Details
Jamie E. Olsen work email
- Valid
- Valid
- Valid
- Valid
Jamie E. Olsen personal email
n/a
About Jamie E. Olsen
Jamie E. Olsen is a Senior Validation Engineer at QuidelOrtho at QuidelOrtho. They possess expertise in lean manufacturing, six sigma, manufacturing, engineering, fmea and 13 more skills.
Jamie E. Olsen Work Experience Details
-
Senior Validation EngineerQuidelortho Jul 2021 - Present -
Quality Systems ManagerThermo Fisher Scientific Oct 2020 - Jul 2021Waltham, Ma, Us -
Quality Assurance Engineering ManagerCoopervision May 2019 - Sep 2020San Ramon, California, Us• Manages, mentors, and trains the QA Engineering team which is responsible for leading CAPA and risk management activities, writing and reviewing validation protocols and final reports, supporting engineering change initiatives, assisting engineering and operations in root cause analysis, managing the calibration schedule, and tracking supplier quality performance• Manages, mentors, and trains the QA Business Unit Training Lead who is responsible for maintaining QA procedures, administering training plans, and participating as an SME in the development and implementation of new processes• Fulfills the site lead role for the risk management, validation, and engineering change order (ECO) processes • Reviews and approves all risk assessments, validation protocols and final reports, ECO’s, and site document changes submitted through the electronic quality management system• Leads a monthly ECO Review Board with the Project Engineering teams to monitor the status of all open ECO’s• Acts as the site lead in global projects to standardize and improve the global and local quality management system• Reports on key performance indicators of the quality management system on a monthly basis and for the annual Management Review -
Quality Assurance ManagerCoopervision Jun 2017 - May 2019San Ramon, California, Us• Managed, mentored, and trained the QA Systems team which is responsible for managing customer complaints, managing the internal audit program, and controlling changes to local procedures• Managed, mentored, and trained the QA Engineering team as outlined above • Regularly reported to the Director of Quality Assurance on the status of site wide quality objectives• Collaborated with the Director of Quality Assurance to facilitate preparation for the site FDA inspection and the Medical Device Single Audit Program (MDSAP) certification audit conducted in 2018• Assisted the Director of Quality Assurance (lead auditee) throughout the site FDA inspection in April 2018• Performed as a lead auditee during the site MDSAP certification audit in August 2018 and has continued to perform as a lead auditee in the annual MDSAP surveillance audits
-
Quality Assurance EngineerCoopervision Dec 2012 - Jun 2017San Ramon, California, Us• Fulfilled the role of site lead for the CAPA, risk management, validation, and ECO processes • Managed the completion of CAPA’s by leading cross-functional teams to determine root causes, and identify and implement corrective and preventive actions• Developed a risk management program that incorporated quality plans, process flow charts, and PFMEA’s for all automated equipment and key processes at the site• Created process flow charts and risk assessments (PFMEA’s) with teams made up of cross-functional leads• Mentored and coached Quality Assurance Technicians on the site’s risk management process• Supported equipment validations by creating validation templates and protocols, statistical sampling plans, deviation reports as needed, and performing the final review of the executed validation protocols• Fulfilled the ECO Change Assessor role to ensure the proper application of risk management and verification of each change order• Actively participated in the global change forum to ensure local changes did not adversely impact other sites• Assisted the Director of Quality Assurance during annual ISO certification audits• Conducted internal audits on various processes throughout the facility• Acted as interim Quality Assurance Supervisor for a period of six months and was responsible for managing a team of thirteen auditors who supported the daily operations of Packaging and Distribution
-
Lean ManagerLapp Insulators Llc Aug 2011 - Nov 2012Le Roy, New York, Us• Applied Lean and 5S principles throughout the manufacturing facility• Led teams in evaluating problem areas and generating improvement ideas• Presented team suggestions to management and supervisors• Met with management, supervisors and other responsible parties on a regular basis to review action items and ensure completion of each action• Wrote/updated standard operating procedures and trained the appropriate workforce• Presented project summaries and updates at all-employee quarterly meetings -
Industrial EngineerLapp Insulators Llc Mar 2007 - Nov 2012Le Roy, New York, Us• Generated costing analyses to provide Sales with costs of new items• Conducted studies of work centers to calculate standard labor hours as well as identify improvements to increase productivity• Developed and maintained routings and BOMs in PDM system• Evaluated and updated packaging material of current items
-
Purchasing AssistantLapp Insulators Llc Apr 2010 - Apr 2012Le Roy, New York, Us• Purchased items from sister companies in Germany, Poland and Romania for sales in the United States• Developed a tracking system to determine the status of active purchase orders• Implemented a report that notified Production Planning of delayed orders to help improve on-time delivery of customer orders• Maintained contact with colleagues in Germany, Poland and Romania on a daily basis by acting as the point of contact for Accounting, Engineering, Production Planning, Receiving and Sales• Traveled to Germany and Romania to tour manufacturing facilities and to strengthen relationships with colleagues at sister companies
-
Quality Assurance Engineering Co-OperativeHarmac Medical Products Jun 2005 - Jun 2006Buffalo, Ny, Us• Monitored and tracked the corrective and preventive action system to reduce the number of late action items• Actively worked with individuals to promote on-time completion of corrective and preventive actions• Updated standard operating procedures to ensure compliance with ISO regulations -
Six Sigma Black Belt ApprenticeMercy Hospital Of Buffalo Sep 2005 - May 2006• Recommended improvements for reducing patient transportation delays between the imaging department and patient rooms
Jamie E. Olsen Skills
Lean Manufacturing
Six Sigma
Manufacturing
Engineering
Fmea
Process Improvement
Iso
Continuous Improvement
Quality Assurance
Capa
Root Cause Analysis
Dmaic
5s
Cross Functional Team Leadership
Quality System
Customer Service
Project Planning
Business Process Improvement
Jamie E. Olsen Education Details
-
University At BuffaloIndustrial Engineering
Frequently Asked Questions about Jamie E. Olsen
What company does Jamie E. Olsen work for?
Jamie E. Olsen works for Quidelortho
What is Jamie E. Olsen's role at the current company?
Jamie E. Olsen's current role is Senior Validation Engineer at QuidelOrtho.
What is Jamie E. Olsen's email address?
Jamie E. Olsen's email address is jo****@****ion.com
What schools did Jamie E. Olsen attend?
Jamie E. Olsen attended University At Buffalo.
What skills is Jamie E. Olsen known for?
Jamie E. Olsen has skills like Lean Manufacturing, Six Sigma, Manufacturing, Engineering, Fmea, Process Improvement, Iso, Continuous Improvement, Quality Assurance, Capa, Root Cause Analysis, Dmaic.
Free Chrome Extension
Find emails, phones & company data instantly
Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial