Jennifer Veit
- Role
- Principal Operations Quality Engineer at Medtronic
- Location
- Minneapolis, MN, US
- LinkedIn followers
- 500 followers
About Jennifer Veit
I lead medical device engineers through the balancing of regulatory compliance…
Experience
Principal Operations Quality Engineer
Dec 2019 — Present
Collaborates with engineering and manufacturing functions to resolve quality issues discovered in operations- Develops, modifies, applies and maintains quality standards for processing materials into product- Devises and implements methods for inspecting, testing and evaluating products and production equipment- Conducts inspections; performs statistical analysis to assess whether product meets required standards and specifications- Ensures corrective measures meet acceptable reliability standards and documentation is compliant with requirements- Investigate and resolve quality & compliance issues - Ensure value stream is compliant with internal and/or external specifications, regulations and standards such as ISO- Create and update procedures as assigned, related to the quality system, operations, and product testing- Apply statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement- Communicate significant issues or developments identified during quality activities and provide recommended process improvements to team or management- Review equipment and process validations, changes, non-conformances, etc, in order to ensure compliance and assess impact on product reliability, process capability and compliance- Review and approve test method validation and stability plans and reports- Provide technical support for laboratory testing in order to ensure root cause analysis and investigative results- Participate in corrective/preventive action teams in resolving production, customer and supplier issues (e.g, nonconformances, sCAPA /CAPA activities, audit findings, complaint investigations, etc.)- Coordinate with other Medtronic facilities to resolve issues and implement best practices- Support internal and external site audits and inspections.* FactoryWorks manufacturing execution system * Drug-device combination products
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