Jill Baker Email & Phone Number

Brecksville, Oh

Primary responsibilities include upgrade of certification to MDSAP with all participating countries and ISO 13485:2016 certification. • Internal Auditor 13485:2003, 13485:2016, 9001:2008, 9001:2015 and MDSAP regulations• International Product Registration with knowledge in registration within 52 countries• Health Canada Device Licensing• MDD to EU MDR project

Cuyahoga Falls, Oh

Primary responsibilities include managing quality systems processes with direct reports• Lead Internal Auditor 13485:2003 and 9001:2008• CAPA System Management/Root Cause Analysis/Corrections, Implementation and Verifications• Complaint System Management• Training system development • Document Control/Procedure and WI creation/Approvals• International Product Registration with knowledge in registration within 52 countries• EPA Submissions/Pesticide Registrations• Quality Records/DHR/DHF• Supplier Management/Supplier Audits/Supplier Reviews and Approvals• Establishment Registration and Device Listings FDA and Health Canada• Certificate to Foreign Governments

Primary responsibilities include policing the CAPA system with issuing, tracking and follow-up on all corrective actions, administrating nonconformance’s resulting from the internal audit process, managing the internal audit team, international product registration, pesticide registrations, Support production with creation of work instructions and PPM’s.• Internal Auditing to ISO 13485:2003 and 9001:2008.• International Product registration• Pesticide Registrations/EPA submissions• Registration of pesticides nationally • Chairperson for the companies community relations committee

Primary responsibilities include managing the ECA process for all drawings, artwork, web paths, specifications, work instructions and procedures. Creation of batch records/ device history record documentation, issuing and reviewing when completed. Customer complaint initiation, review and closure. CAPA issuance, monitoring, follow-up, and validation/verification of issues relating to this system, Issuing training records, tracking and maintaining training records. Strict company, regulatory guidelines and processes to be followed.• Routing documents such as ECA’s, deviations, and processes.• Support production with creation of batch records, procedures and work instructions..• Support Engineering with both product and process optimization• Supporting HR and Production by issuing, tracking and maintaining personnel training. • Internal Auditing to ISO 13485:2003 and 9001:2008.• Customer complaints

Document Control AdministratorPrimary responsibilities include policing the CAPA system with issuing, tracking and follow-up on all corrective actions, customer complaint review and closure, international product registration, pesticide registrations. Duties include document control of specifications, work instructions, ppm’s, management review and customer focus, validation/verification of issues relating to the CAPA system, device history record documentationSupport production with creation of work instructions and PPM’s.• Team board development and daily interaction with cross functional teams to identify and support continuous improvement• Internal Auditing to ISO 13485:2003 and 9001:2008.• Notarize official/legal company documents• International Product registration• Registration of pesticides nationally • Chairperson for the companies community relations committee