Robert Waldron Email & Phone Number

Evanston, Il, Us

Waltham, Ma, Us

Responsible for driving the strategic development and deployment of the Clinical Trials Division Mt. Prospect, IL Quality Management System; ensuring compliance across all cGMP activities while cultivating a culture of quality and collaboration.

Waltham, Ma, Us

Austin, Texas, Us

Interface with supplier and distributor engineering and quality organizations to efficiently address reported problems impacting functionality, quality, and regulatory requirements.Maintain and monitor approved supplier and distributor lists (ASLs) in compliance with proceduresLead supplier new part qualification activities, including development of capability studies and control plans that define the supplier's processes and identify areas of risk.Review and approve engineering design changes and supplier change requests to determine part re-qualification needs.Work with design engineering to determine receiving inspection requirements of purchased components and finished product.Request Supplier Corrective Action plan from supplier, based on negative-trending issues from monthly quality data reports.Active member of Change Control team when the proposed change affects suppliers by ensuring timely communication.Work with Quality, Regulatory and Supply Chain Managers to develop and prioritize a supplier audit schedule.Perform supplier audits, qualifications and re-qualifications.Work directly with suppliers to ensure proper root cause investigations and mitigation activities.Provide direction to suppliers in implementing Incoming Inspection Plans, First Article Inspection, In-Process and Final Product Inspection, FMEAs, Sampling Plans, inspection and test acceptance criteria, and handling non-conformances/CAPA.

Mumbai, In

Mumbai, In

Mumbai, In

Mumbai, In

M.S., Quality Assurance & Regulatory Science

Bs, Management