Tracie Davis Email & Phone Number

COMPANY OWNERPerforming consulting auditing services for Quality Management System compliance for clients. Services include project management, quality assurance, training, and QMS establishment and ISO 13485 certification readiness.Managed daily operations, staffing, training, human resources and accounting activities. Implemented standard operating procedures and applied 5S methodologies and lean manufacturing principles to reduce cycle times and errors and optimize processes.

Miramar, Fl, Us

Implemented Quality Management System processes for compliance to regulatory requirements and continuous quality improvement milestones and risk management activities. Managed business and quality systems to support strategic direction by planning and executing activities, actively lead and motivated the Systems team while supporting Quality Assurance Engineering product development team including management of 5 direct staff and 1 indirect. Managed all CAPA activities, provided change control documentation management, and nonconforming system management. Planned, budgeted, and oversaw all aspects of deliverables within the department including implementation of cross functional projects interdepartmentally assuring no gaps between systems, use, training, and compliance within a complex business model. Managed internal and external audit activities and regulatory responses.

Abbott Park, Illinois, Us

Implemented global Quality Management System processes including Complaint Handling, CAPA, Nonconformances, Supplier Quality, Documentation Control, Training, Internal and External Auditing and Product & Process Controls for informatics solution products. Formed a quality staff of 8 and together established a full QMS in compliance with 21 CFR 820 and ISO 13485 within six months enabling the company to obtain on-time ISO 13485 certification.

Kalamazoo, Mi, Us

Managed Quality Operations for two Stryker facilities including supplier quality, receiving inspection, quality operations, complaint handling, calibration, preventive maintenance, and training departments leading 14 direct staff and 8 indirect staff. Improved Quality Compliance to obtain a state of audit readiness. Significantly reduced the rate of nonconformances by 50% by correlating vendor inspection methods and partnering with the Design team to challenge specifications. Supported and drove the execution of complex projects including the implementation of Dock to Stock and Supplied Data programs for incoming parts. Drove CAPA execution and implemented Quality Operations metric performance tracking.

Boca Raton, Fl, Us

CONTRACT POSITIONRecreated entire Quality Management System including the development of Quality Standard Operating Procedures, production procedures and forms. Provided training for entire organization. Developed FDA 483 audit responses. Created, managed and executed Corrective and Preventive Action plans. Created and submitted FDA 510K applications. Ensured organizational compliance with FDA 21 CFR 820 Medical Device Regulations.

Marlborough, Ma, Us

Led 36 combined direct and indirect reports improving the quality of incoming materials and elevating vendor quality controls and verifications. Attained and improved key global and site metrics for supplier quality. Assisted Miami plant achievement of zero nonconformances in seven consecutive major external audits through proper execution of supplier audit documentation, corrective action activity and nonconformances.

Marlborough, Ma, Us

Managed manufacturing engineering resources and projects for multiple business units valued at over $222M. Improved key business and quality metrics including yields, cycle times, downtimes, efficiencies, and compliance. Championed continuous improvement through CAPA ownership, lean manufacturing implementations, nonconforming event resolutions, and process improvements. Supported and drove execution of complex projects, equipment installations and CAPA activities applying DMAIC methodologies resulting in significant defect reduction and increased efficiencies.

Marlborough, Ma, Us

Provided engineering staff mentorship and training while supporting extensive continuous improvement projects and validations for Cardiac and Endoscopic guidewire products. Implemented new products including Meier guidewires and IQ guidewires. Created production and quality documentation, performed engineering evaluations, Design of Experiments, qualifications and validations, and developed and executed project improvement plans. Executed continuous improvement projects leading to efficiency and yield improvements resulting in savings of $3M.

Marlborough, Ma, Us

Documented and investigated nonconforming products, executed CAPA activities, evaluated production issues to identify resolutions, and implemented improved control methods including Statistical Process Control. Ensured attainment of quality, yield, output, and efficiency metrics for product lines. Performed project management, test validations, equipment qualifications, creation of manufacturing production and quality documentation, engineering evaluations, Design of Experiments, and training. Created Technical Dossiers and 510K documentation.

Marlborough, Ma, Us

Designed and developed medical devices, including creation of manufacturing equipment, development of production lines, creation of procedures and operator training. Supported product transfers and validation activities. Performed predicate device testing for 510K submissions to the FDA for various products.