Leanne Olson Email & Phone Number

Support 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.

Maintain 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

Middleton, Wisconsin, Us

Analyze 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.

San Diego, Ca, Us

Performed 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.

Us

Performed 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.

Marlborough, Ma, Us

Responsible 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.