Brad Elder Email and Phone Number

- Responsible for execution and implementation of validation initiatives at the site. - Maintained the Validation Master Plan- Trained and educated associates to the BD Validation procedures and best practices- Developed a validation support structure. - Set goals for continuous improvement of the validation process and tracked key metrics.- Provided support to validation practitioners by providing guidance regarding assembling an appropriate team and strategy development.- Acted as a mentor associates on process, software, and equipment validations.- Participated in management review and executive steering committee meetings to report on validation status.

- Working with Operations and Engineering to maintain production. - Conducting root cause analyses and implementing corrective actions for defective product found on the line and complaints received from customers. - Leading the writing and execution of Measurement System Analysis protocols and reports. - Assisting in the writing and execution of Process Validation protocols and reports. - Consistently improving work instructions, data sheets and the quality plan to ensure that they adequately mitigate risks.

Worked with R&D, Marketing, Medical Affairs & Regulatory Affairs Specialists to generate and implement Design Changes. This was done by ensuring that the Quality System was followed including Design Controls (21 CFR 820 and ISO13485) and Risk Management (ISO 14971, FMEA and Human Factors studies). Analyzed complaints for trends. Authored reports to investigate & correct causes of product failures and assess their impact on our Customers. Statistical analysis of product performance using Minitab to identify a distribution and calculate a Cpk. Assisted and led audits of various departments.

Student of Bioengineering

• Worked to create a tendon repair device• Created an experiment to find the optimal device pattern• Worked mostly unsupervised to accomplish task