Rex A. White Email & Phone Number

Leesburg, In, Us

Midwest

Regulatory compliance/quality professional in the medical device industry. Auditor for manufacturing sites, supplier audits and qualifications. Is able to review quality systems to identify gaps and strengthen the quality system into a state of compliance. Operations/quality partner that creates a comprehensive understanding of the quality system regulations.Knowledge of quality system regulations in accordance with 21 CFR Parts 11, 210, 211, 820, 1271 and ISO 13485 and 14971.

Warsaw

Responsible for all quality assurance activities (process and supplier quality engineering, gauge development and calibration, FAI, and continuous improvement) throughout the Americas and Puerto Rico facilities. Responsible for all regulatory compliance activities (3rd party assessments, internal auditing, DHF review and approval, PMS generation, complaint handling, CAPA system, and quality system management). Responsible for quality planning (product and process planning).Facilitate 3rd party (FDA, Notified Bodies) quality system, process, and product audits. Special processes and software validation studies, i.e., protocols, reporting, and summaries are performed as needed. Oversees the corrective and preventive actions (CAPA) program and maintains database. Maintains open communication with all departments. Maintains annual budget and communicates company and departmental objectives to subordinates. Administers company policies (corporate best practice).

Warsaw

Management Representative at the Warsaw facility. Responsible for all regulatory compliance activities (3rd party assessments, internal auditing, DHF review and approval, complaint handling, CAPA system, and quality system management). Responsible for all quality assurance activities (design, process, and supplier quality engineering, gauge development and calibration, inspection criteria development, FAI, and continuous improvement). QA/RC reporting responsibilities at Biomet sites in Warsaw, In, Fair Lawn, NJ, Miami, FL, Irvine, CA, and two facilities in China.

Warsaw, In

Management Representative at the Warsaw facility. Responsible for all regulatory compliance activities (3rd party assessments, internal auditing, DHF review and approval, PMS generation, complaint handling, CAPA system, and quality system management). Responsible for all quality assurance activities (design, process, and supplier quality engineering, gauge development and calibration, inspection criteria development, FAI, and continuous improvement).

Warsaw, In

• Responsible for the regulatory compliance department at the Warsaw and Fair Lawn facilities.• Scheduling of quality system, process, and product audits.• FDA investigations and BSI assessments are performed as required.• Special processes requiring validation studies, i.e., protocols, reporting, and summaries are performed as needed.• Oversees the corrective and preventive actions (CAPA) program and maintains database.• Maintains open communication with all departments.• Maintains annual budget and communicates company and departmental objectives to subordinates.• Management Representative at the Warsaw, IN and Fair Lawn, NJ facilities. • Administers company policies.

Warsaw, In

Warsaw, In

Warsaw, In

• Responsible for quality engineering within the knee team, which was the first integrated work team.• Establishes and maintains criterion for projects.• Designs gauging for shop floor applications and trains team members on their usage.• Implements corrective and preventive actions based on deviation trend analysis reports.• Supervises the Metrology Laboratory and departmental quality clerks.

Warsaw, In

Bs, Organizational Management

Aas, Mechanical Engineering Technology

Education record