Karim Kutchi

• Serve as quality oversight (QA) for all non-product systems, spreadsheets and reports at Medtronic Diabetes
• Lead remediation effort for CAPAs
• Guide system teams to create validation and quality documents as per internal procedures and regulatory requirements
• Lead validation efforts within internal Quality team Provide project updates, escalate risks to upper management as needed
• Draft SOPs to support exiting QMS
• Provide audit support for internal and external audits
• Support Mobile Medical Application (MMA) validation activities
• Review upcoming and existing quality system documents for compliance (in accordance with 21 cfr parts 820 & 11, iso 13485 etc.)

Client: Medtronic Inc., CA

Project Manager/Quality Assurance / Validation

• Project 1: The project involved identifying various non-compliant systems, reports and processes and validating them
• In addition, it involved identifying gaps in existing validated systems[Duration: 2017-2020]
• Project 2: Lead validation activities for SmartSolve, the new complaint handling software for Medtronic Diabetes[2016-2017]
• Project 3: Served as Quality oversight for all non-product quality systems (20-30 systems) [2018-2020]

Client: Caris Life Sciences, AZ

Sr Validation Consultant

• Project: The project involved providing guidance to help client validate various GxP equipment and software which were CLIA certified
• Created quality documentation to help client obtain FDA approval [Oct 2019- Feb'2020]

Client: Nemera Healthcare, IL

Project Engineer

• Project 1: The project involved delivering automated pharmaceutical manufacturing equipment to the end client
• This also includes equipment testing and validation as per FDA rules and regulation [Sept'2014-Nov'2014]
• Project 2: Led validation engineering scope of work for multiple semi-automated medical device assembly machine projects [Jan'2017- Aug'2017]

Client: Rexam/Eli Lilly, Chicago, IL

Technical Writer

• Project: Drafted Functional Design Specification document for a pad printer used in medical device manufacturing [Oct'2015-Jan'2016]

Client: Eli Lilly, Indianapolis, IN

Project Engineer

• Project: Provided technical guidance on current Industry/Regulatory Compliance
• Drafted Technical Reports [Jan'2017-Aug'2017]
• Additional Responsibilities
• Prepared technical reports on Project Management, Cold Chain Management, Commissioning & Qualification and GEPs
• Business Development (Attended client meetings and conferences)

Client: Lifescan (Johnson & Johnson)

• Project: The project involved validating JIRA (version 7.0) for their product development/bug tracking cycle in accordance to the company's SDLC policy
• Implementation also included validating JIRA as a customer complaints management software

• Project Management: Marketing and development of a biotech lab in the Pittsburgh region (The Citizen Science Lab)
• Research Advisor