
luke stark
quality assurance medical device development
About
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, and other life sciences. I spent a year working as a quality engineer for a dietary supplement manufacturer getting to explore hands on experience with preventive maintenance, RO water systems, and other day-to-day activities. In March of 2015, I launched my journey into electronics manufacturing quality.
united states
indianapolis
pharmaceuticals
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
Experience

quality engineer
living essentials
I provided quality input in the preventive maintenance process including implementing a computerized maintenance solution to improve PM data gathering and completion. I was given direct responsibility over the operation of a RO Water system ensuring proper operation, maintenance, and general stewardship. Other activities included creating validation testing documents, SOP creation, and general auditing of operations and engineering processes.

validation engineer and project leader
performance validation
I provide validation and qualification activities for pharmaceutical manufacturing systems and data management systems. I also provide insight on how to improve quality systems and how to better enable a client to maintain suitability for their quality system.

validation contractor - performance validation
eli lilly and company
I created: periodic reviews (periodic quality evaluations), quality plans for installing/updating equipment, I create qualification documents to test the suitability of equipment.

student
rose-hulman institute of technology
I majored in computer engineering. I received a minor in literature and language. I was the Co-Editor-in-Chief of the school newspaper for 2 years.

product quality assurance
technicolor
Exploring a new side of quality assurance in electronics. I work with a worldwide team to ensure process driven design and implementation of customer needs. I also provide SPC input to our worldwide manufacturing team to ensure quality criteria are met for product released to the customer.

quality assurance medical device development
eli lilly and company
Lilly is a global health care leader that unites caring with discovery to make life better for peoplearound the world. For more than a century, we have stayed true to a core set of values—excellence,integrity, and respect for people—that guide us in all we do: discovering medicines that meet realneeds, improving the understanding and management of disease, and giving back to communitiesthrough philanthropy and volunteerism.
Education
henryville junior - senior high school
silver creek high school
rose - hulman institute of technology
english language
luke stark's Contact Information
Phone
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