Amanda O'Shell Email & Phone Number

Grand Rapids, Mi

Responsible for timely and accurate management of Perrigo documentation and data including document change orders, manufacturing documentation, engineering drawings, BOMs, parts lists, specification and any other data, documents or records that are created and maintained as part of a product's life cycle. Currently support internal, external and third party audits, DMR and DHF maintenance, Learning Management System input, development and maintenance of quality metrics and continuous… Show more Responsible for timely and accurate management of Perrigo documentation and data including document change orders, manufacturing documentation, engineering drawings, BOMs, parts lists, specification and any other data, documents or records that are created and maintained as part of a product's life cycle. Currently support internal, external and third party audits, DMR and DHF maintenance, Learning Management System input, development and maintenance of quality metrics and continuous improvement activities. Show less

Mange complaint records in accordance with documents procedures that reflect regional regulator and certification requirements; ISO 13485, FDA 21 CFR 820, 21 CFR 803, Health Canada and BRCGS Consumer Products. Perform complaint medical devise adverse event reporting to applicable authorities. Diffuse/handle volatile discussions with consumers, working to archive a positive outcome for customer whenever possible. Support Quality Engineering staff in complaint/product investigations. Identify… Show more Mange complaint records in accordance with documents procedures that reflect regional regulator and certification requirements; ISO 13485, FDA 21 CFR 820, 21 CFR 803, Health Canada and BRCGS Consumer Products. Perform complaint medical devise adverse event reporting to applicable authorities. Diffuse/handle volatile discussions with consumers, working to archive a positive outcome for customer whenever possible. Support Quality Engineering staff in complaint/product investigations. Identify unique situations, high risk complaints and increasing complaint trends and escalate to management. Support regulatory inspections and quality audits. Show less

Greater Grand Rapids, Michigan Area

Consult and collaborate with leadership teams to design wellness programs across the West Michigan area. Provide onsite health coaching and incentive programs to improve employee health and drive worker productivity. Responsible for creating, implementing and delivering numerous wellness presentations. Design and implement program evaluation tools so customers can maximize their ROI. Lead biometric screenings; including working with multiple vendors and staffing. Coordinate multiple… Show more Consult and collaborate with leadership teams to design wellness programs across the West Michigan area. Provide onsite health coaching and incentive programs to improve employee health and drive worker productivity. Responsible for creating, implementing and delivering numerous wellness presentations. Design and implement program evaluation tools so customers can maximize their ROI. Lead biometric screenings; including working with multiple vendors and staffing. Coordinate multiple corporate staff and/or vendors for fitness classes, health fairs, presentations and special events. Show less