Leanne Olson work email
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Leanne Olson personal email
Leanne Olson is a Sr. Specialist Quality Engineering & Validation at BRISTOL MYERS SQUIBB, JUNO THERAPEUTICS at BRISTOL MYERS SQUIBB, JUNO THERAPEUTICS. She possess expertise in manufacturing engineering, medical devices, process engineering, new product validation, fda and 9 more skills.
Bristol Myers Squibb, Juno Therapeutics
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Qa Associate IiBristol Myers Squibb, Juno Therapeutics Aug 2019 - PresentSupport routine clinical and commercial production to ensure consistent compliance with regulatory and industry expectations. Review and approve complex documentation in support of GMP operations, including but not limited to equipment, facility, and utility changes. Utilize Blue Mountain Regulatory Asset Manager software and Valgenesis validation software. Review and approve quality documents for Quality Assurance role in Veeva Vault Clinical Data Management.
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Qms EngineerPhilips Healthcare Nov 2018 - May 2019Maintain a compliant and effective Quality Management System for Quality & Regulatory processes. Participate in Q&R initiatives as a cross functional contributor. Ensure external and internal audit readiness and provide support during audits. QMS on EU Medical Device Regulation compliance project. Improve training administration processes to Quality & Regulatory employees using TEDS Learning Management
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Medical Device Documentation EngineerNatus Medical Incorporated Jul 2015 - Jul 2018Middleton, Wisconsin, UsAnalyze product requirements and traceability from design inputs throughout the design control process. Evaluate product requirements against FDA 510(k) submissions, technical files, and NRTL test reports. Utilizing document to address gaps in design history file documentation for existing product lines. DHF remediation. -
Sr. Manufacturing EngineerVolcano Corporation Jan 2004 - Jul 2006San Diego, Ca, UsPerformed manufacturing process review and improvement implementation to increase productivity and ensure quality compliance. Performed quality audits in close collaboration with Quality Engineering. Created Change Requests and Change Orders for mechanical changes and coordinated their release.Investigated and responded to Corrective and Preventive Actions (CAPA).Reviewed design and documentation of product from incoming inspection to packaging to ensure compliance with design criteria and standards. -
Development Engineering ManagerCholestech Jun 2001 - Jan 2004UsPerformed FMECA/Hazard Analysis of IVD system. Worked with chemists to design new IVD tests utilizing AutoCAD and SolidWorks. Directed R&D team activities and resources.Served on documentation change control and nonconformance material review boards with different departments.Designed and analyzed mechanical parts and systems. Developed and documented design requirements. -
Sr. Manufacturing EngineerBoston Scientific May 2000 - Jun 2001Marlborough, Ma, UsResponsible for engineering production line support of high-profile electrophysiology catheter.Optimized process efficiency and production accuracy via implementation of new document change order system.Transferred mission-critical manufacturing process in-house; verified all FDA requirements and validation protocols.
Leanne Olson Skills
Leanne Olson Education Details
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University Of ManitobaMechanical Engineering
Frequently Asked Questions about Leanne Olson
What company does Leanne Olson work for?
Leanne Olson works for Bristol Myers Squibb, Juno Therapeutics
What is Leanne Olson's role at the current company?
Leanne Olson's current role is Sr. Specialist Quality Engineering & Validation at BRISTOL MYERS SQUIBB, JUNO THERAPEUTICS.
What is Leanne Olson's email address?
Leanne Olson's email address is le****@****tus.com
What schools did Leanne Olson attend?
Leanne Olson attended University Of Manitoba.
What skills is Leanne Olson known for?
Leanne Olson has skills like Manufacturing Engineering, Medical Devices, Process Engineering, New Product Validation, Fda, Quality System, Biomedical Engineering, Iso 13485, Design Of Experiments, Engineering, Design Control, Manufacturing.
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