Allen Stapleton Email & Phone Number

Quality Systems Engineer

Bothell, Washington, Us

• Manage Global Complaint Management and Global Vigilance Reporting processes and designated Complaint Handling Unit. Coordinate interfaces and training activities with worldwide Complaint Processing Teams. • Responsible to assess complaints against regulatory agency reporting requirements and ensure required reports are submitted within required time limits. (MDR, MPR, MIR)• Analyze and provide complaint data and other post market surveillance information to cross functional teams and senior management.• Ensured seamless communications between the Complaint Handling, Regulatory, Engineering, Medical and CAPA teams to promote continuous product quality improvement, promote quality plan awareness, and ensure execution to plan.• Coordinate recall activities as required• Assist development of Risk Management documentation (FMEAs, Hazard Analysis, and Risk Analysis).

Bothell, Washington, Us

• Managed Quality Assurance and Document Control departments.• Maintained Quality System compliance with ISO 13485 and 21 CFR 820 requirements• Prepared and presented Quality System Management Reviews and trend analysis• Developed and maintained component, assembly, and finished goods Quality Control Plans• Responsible for CAPA, Failure Investigation, Non-conforming Material processes• Managed document control process and provide change request approval• Managed supplier qualification process• Conducted new product design risk analysis• Prepared verification and validation plans• Hosted TUV and FDA surveillance audits/inspections • Mentored team development and conducted employee performance reviews• Developed cost of quality matrix to identify top quality issues; used results to drive focused quality improvement projects• Provided quality systems guidance to new product development team to ensure compliance to regulatory body regulations, guidelines, and company processes

Bothell, Washington, Us

• Led Quality Assurance team daily activities (receiving, in-process, final inspection; non-conforming material; CAPA; failure investigation, change control)• Developed and executed IQ, OQ and PQ protocols• Dispositioned non-conforming material; provided solutions to prevent re-occurrence• Drove CAPA activities for high risk or trended issues.• Evaluated and approve supplier qualifications• Responsible for calibration and maintenance processes

Bothell, Washington, Us

• Responsible for receiving inspection, final inspection• MRB coordinator• Executed process and product validations• Document Control system administrator