Sara Dailey Email & Phone Number

Franklin Township, Nj, Us

Franklin Township, Nj, Us

Somerset, New Jersey, Us

Parsippany, Nj - New Jersey, Us

• Lead quality engineer supporting the ELEOS Limb Salvage System product line• Manage and execute the complaint process and brought all interim KPIs to an overall green metric• Own and support CAPAs towards timely root cause investigation, implementation, and closure • Collaborate with suppliers regarding non-conformances, supplier corrective action requests, and production part approval process documents• Support manufacturing transfers of 120 instruments by executing appropriate quality activities• Initiate and own non-conformance reports through containment, disposition, and closure• Assist with changes to engineering drawings, operation specifications, and risk documentation• Perform device history record review for 11 suppliers and ensure product conforms to engineering drawing and specifications• Submit initial and supplemental FDA MedWatch reports for reportable complaints in a timely manner • Conduct quality reviews of verification and validation test protocols and reports• Key presenter for monthly quality review meetings and quality management reviews

Parsippany, Nj - New Jersey, Us

• Lead quality engineer supporting the ELEOS Limb Salvage System product line• Manage and execute the complaint process and brought all interim KPIs to an overall green metric• Own and support CAPAs towards timely root cause investigation, implementation, and closure • Collaborate with suppliers regarding non-conformances, supplier corrective action requests, and production part approval process documents• Initiate and own non-conformance reports through containment, disposition, and closure• Assist with changes to engineering drawings, operation specifications, and risk documentation• Perform device history record review for 11 suppliers and ensure product conforms to engineering drawing and specifications• Submit initial and supplemental FDA MedWatch reports for reportable complaints in a timely manner • Conduct quality reviews of verification and validation test protocols and reports• Key presenter for monthly quality review meetings and quality management reviews

Marlton, New Jersey, Us

• Collaborated with product development on the required risk documentation for design control phases• Wrote and updated SOPs, specifications, quality plans, and other quality documents • Reviewed supplier requests, completed necessary qualification documentation, and maintained the Approved Supplier List• Prepared quarterly metrics for upper management• Assisted with CAPA, receiving inspection, and product labeling

Warsaw, Indiana, Us

• Reduced the complaint backlog from approximately 300 to 0 while maintaining a green KPI complaint metric• Lead engineer performing electrical and mechanical testing on complaint medical device returns to pinpoint failure • Submit initial and supplemental FDA MedWatch reports for reportable complaints in a timely manner • Conduct data analysis for complaint trending activities to assist overall post market surveillance• Key presenter for monthly complaint metric meetings

Raritan, New Jersey, Us

• Led the reintroduction of the On The Spot recognition program to incentivize employees and ensure operational excellence • Maintained the PES Market Intelligence site and ERICA database to assure current and accurate data was available• Assisted in the coordination of quarterly financials

Princeton, Nj, Us

• Compiled, investigated, and resolved incomplete Advanced Placement Testing cases• Learned ETS proprietary software programs including IDMS, imsWeb, and SentReporter• Trained staff in implementing resolution procedures

New York, Ny, Us

• Maintained and initiated constant presence on sales floor to address customer needs• Approached customers and clarified buying preferences to promote sales

• Scheduled daily activities designed to engage and stimulate campers• Resolved conflicts between campers, assessed injuries, and maintained a safe camp environment