Luke Stark

Luke Stark Email and Phone Number

Quality Assurance Medical Device Development at Eli Lilly and Company @ Eli Lilly and Company
indianapolis, indiana, united states
Luke Stark's Location
Indianapolis, Indiana, United States, United States
Luke Stark's Contact Details
About Luke Stark

In my first position out of school, I spent 8.5 years learning about life sciences quality systems while working as a consultant (project manager, validation, auditing, etc) in the realm of pharmaceutical and medical device manufacturing. During this time I was able to experience a wide range of clients from large corporations to small laboratories. Learning GxP and risk application of validation and quality principles helped form a solid understanding of quality systems and application of FDA regulatory requirements.I spent a year working as a quality engineer for a dietary supplement manufacturer getting to explore hands on quality engineering with preventive maintenance, RO water systems, and other day-to-day activities. This position leveraged my engineering background and expanded on my understanding of quality. Allowing quality and manufacturing to work together to create product with the least oversight necessary to function.In March of 2015, I launched a journey into electronics manufacturing quality. Working with an international team allowed me to improve my understanding of manufacturing techniques and systems measurements. I was able to implement and improve on the quality metrics used to determine how well the manufacturing site was operating. My improvements to the quality metrics provided a way to understand re-work issues and allowed us to be more aligned with people across the globe.In June 2016, I returned to the life sciences and began a position in medical device development quality assurance. This has leveraged my understanding of quality systems and FDA regulatory requirements. I am concurrently working on process improvement by modernizing and aligning procedures with current practices and technology while being a quality representative on several development teams. I am always learning more about clinical trials, global procurement, contract service providers, contract manufacturers, and transferring devices to manufacturing.

Luke Stark's Current Company Details
Eli Lilly and Company

Eli Lilly And Company

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Quality Assurance Medical Device Development at Eli Lilly and Company
indianapolis, indiana, united states
Website:
lilly.com
Employees:
37008
Luke Stark Work Experience Details
  • Eli Lilly And Company
    Senior Principal Associate Quality Assurance, Device Development
    Eli Lilly And Company Jun 2016 - Present
    Ltc-N, Indianapolis
  • Technicolor
    Product Quality Assurance
    Technicolor Mar 2015 - Jun 2016
    Indianapolis, Indiana Area
  • Living Essentials
    Quality Engineer
    Living Essentials Jan 2014 - Mar 2015
    Wabash, In
  • Performance Validation
    Validation Engineer And Project Leader
    Performance Validation Jun 2005 - Jan 2014
  • Eli Lilly And Company
    Validation Contractor - Performance Validation
    Eli Lilly And Company 2005 - Jan 2014
  • Rose-Hulman Institute Of Technology
    Student
    Rose-Hulman Institute Of Technology 2001 - May 2005

Luke Stark Skills

Cqa Pharmaceutical Industry Validation Fda Gmp Capa Medical Devices Quality Assurance 21 Cfr Part 11 Quality System Process Improvement Technical Writing Sop Continuous Improvement Lean Manufacturing Root Cause Analysis Manufacturing Quality Management Cqe Leadership Computer System Validation Change Control Testing Gamp Gxp Cleaning Validation Iso 13485 U.s. Food And Drug Administration Standard Operating Procedure Corrective And Preventive Action

Luke Stark Education Details

Frequently Asked Questions about Luke Stark

What company does Luke Stark work for?

Luke Stark works for Eli Lilly And Company

What is Luke Stark's role at the current company?

Luke Stark's current role is Quality Assurance Medical Device Development at Eli Lilly and Company.

What is Luke Stark's email address?

Luke Stark's email address is lu****@****ail.com

What is Luke Stark's direct phone number?

Luke Stark's direct phone number is +131745*****

What schools did Luke Stark attend?

Luke Stark attended Rose-Hulman Institute Of Technology.

What skills is Luke Stark known for?

Luke Stark has skills like Cqa, Pharmaceutical Industry, Validation, Fda, Gmp, Capa, Medical Devices, Quality Assurance, 21 Cfr Part 11, Quality System, Process Improvement, Technical Writing.

Who are Luke Stark's colleagues?

Luke Stark's colleagues are Daniela Ramírez Ramírez, Priscille Ludwikowski, David Shaw, Jerôme Sedee, Tony Zhang, Patrick Binnert, Astrid Torstensson.

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