Marie Graves Email & Phone Number | Accomplished Quality Assurance Compliance Professional with over 15 years of expertise in the regulated medical device industry. A proven track record of hosting and managing FDA and ISO audits, resulting in best-in-class inspections with work examples of 100% compliance improvement in external regulatory inspection outcomes. Expert in supplier and distribution management, US & EU regulatory submissions, and Post Market Surveillance. Adept in handling customer complaints and overseeing CAPA processes, ensuring timely resolution. Known for meticulous attention to detail, strong communication skills, and the ability to work independently. Demonstrated expertise in ISO 13485 quality systems, medical device regulations, and active implantable medical devices. Exceptional knowledge of MDSAP and 5 participating country requirements. KEY COMPETENCIES • Internal Auditing (ASQ-CQA) • External Audit Management (FDA i.e. CDRH, CBER, including PAI’s & ISO NB’s) • Supplier & Distributor Auditing and Quality Agreement Management • Regulatory submissions (MDD to MDR transitions, 510(k)s, IDEs, PMAs) & Standards management • Customer Complaint Handling (including service records), Medical Device & Vigilance Reporting • Corrective and Preventive Action Investigation & Management • Document Control (eQMS’s: TrackWise, Master Control, QCBD, Agile, SAP, ETQ, FreeQMS) • Nonconformance Processing and Product disposition reviews (MRB) • Quality Assurance Training Administration • Clinical Evaluation experience, pre & post market clinical data monitoring • Contributor / reviewer on validation protocols & reports (Specializing in Biocompatibility) • Quality Batch Review and Release • Clinical study site startup, monitoring, TMF closure

Marie Graves

Accomplished Quality Assurance Compliance Professional with over 15 years of expertise in the regula...
United States

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Marie Graves’s Email marie_graves@bd.com

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Work Experience

Bangladesh

Senior Manager, Corporate Quality Audit Operations and Systems

Present

Immune

Consultant, Quality & Regulatory

2019-06-01 00:00:00 - 2023-11-01 00:00:00

Djo

Regulatory And Quality Compliance - Global Audit Program Manager

2018-05-01 00:00:00 - 2019-06-01 00:00:00

Nuvasive

Quality Assurance Manager

2017-07-01 00:00:00 - 2018-05-01 00:00:00

Pfm Medical

Quality Assurance Manager

2015-08-01 00:00:00 - 2017-07-01 00:00:00

Imthera Medical

Quality Assurance Manager

2013-10-01 00:00:00 - 2015-08-01 00:00:00

Sangart

Qa Supply Chain Manager

2012-07-01 00:00:00 - 2013-10-01 00:00:00

Gen Probe

Quality Assurance Compliance Audit Specialist Iii

2008-03-01 00:00:00 - 2012-07-01 00:00:00

Syntron Bioresearch

Quality Assurance Manager

2007-07-01 00:00:00 - 2008-03-01 00:00:00

Skills

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Languages

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FAQ About Marie Graves

Marie Graves is located at
United States

Marie Graves is a Accomplished Quality Assurance Compliance Professional with over 15 years of expertise in the regulated medical device industry. A proven track record of hosting and managing FDA and ISO audits, resulting in best-in-class inspections with work examples of 100% compliance improvement in external regulatory inspection outcomes. Expert in supplier and distribution management, US & EU regulatory submissions, and Post Market Surveillance. Adept in handling customer complaints and overseeing CAPA processes, ensuring timely resolution. Known for meticulous attention to detail, strong communication skills, and the ability to work independently. Demonstrated expertise in ISO 13485 quality systems, medical device regulations, and active implantable medical devices. Exceptional knowledge of MDSAP and 5 participating country requirements. KEY COMPETENCIES • Internal Auditing (ASQ-CQA) • External Audit Management (FDA i.e. CDRH, CBER, including PAI’s & ISO NB’s) • Supplier & Distributor Auditing and Quality Agreement Management • Regulatory submissions (MDD to MDR transitions, 510(k)s, IDEs, PMAs) & Standards management • Customer Complaint Handling (including service records), Medical Device & Vigilance Reporting • Corrective and Preventive Action Investigation & Management • Document Control (eQMS’s: TrackWise, Master Control, QCBD, Agile, SAP, ETQ, FreeQMS) • Nonconformance Processing and Product disposition reviews (MRB) • Quality Assurance Training Administration • Clinical Evaluation experience, pre & post market clinical data monitoring • Contributor / reviewer on validation protocols & reports (Specializing in Biocompatibility) • Quality Batch Review and Release • Clinical study site startup, monitoring, TMF closure

Marie Graves currently works in the

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Marie Graves has prior
experience in the following industries:
Immune | Djo | Nuvasive | Pfm Medical | Imthera Medical | Sangart | Gen Probe | Syntron Bioresearch

Marie Graves has the following professional experience:
Bangladesh | Immune | Djo | Nuvasive | Pfm Medical | Imthera Medical | Sangart | Gen Probe | Syntron Bioresearch