Linda Locke Email & Phone Number

Germantown, TN, US

United States

• Oversaw and managed QC process to ensure compliance with all standards and regulations. Led 15-25 direct and indirect reports, guided engineers to incorporate Hazardous Substance and Human Factors as required by laws.
• Led remediation of 13K+ SKUs and managed quality of 60 technical files and 57 projects.
• Realigned focus for failing team by clarifying objectives, eliminating non-critical tasks, creating accountability for team members, and aligning individual and team goals, resulting in on-time delivery within six.
• Spearheaded cross-functional hiring and training initiative to resolve critical resource constraints and bring project delivery in alignment with internal goals.

Greater Memphis Area

• Managed 6 direct and indirect reports, maintained quality system in functional areas of custom, patient specific and stocked products, and ensured compliance and release of product according to specifications..
• Oversaw quality function associated with servicing and repairing orthopaedic instruments, led team to transfer endoscopy product into orthopaedic division, and supervised design control function including FMEA and.
• Led cross-functional team to create and implement software medical device quality system and identify root causes in response to CAPA activities.
• Performed management review, supported 510K activities, provided employee development and mentoring, and acted as UDI implementation team member.

Education record

Masters Of Science, Engineering Management