Medpoint » Management

W.W.W.

PECULIAR — Thu, 30 Oct 2008 17:04:57 +0000

CQE with twenty seven years of experience in the Medical Device and Biomedical industries. In- depth knowledge of Regulations and Standards: QSR, ISO 13485, Canadian Medial Devices Conformity Assessment System (CMDCAS), ISO 14971, 21 CFR 1270 & 1271 (Human Tissue).

Titles Held: Vice-President, Quality Assurance; Director of Quality Assurance; Divisional Quality Assurance Engineering Manager; Quality Assurance Supervisor; Production Supervisor

Substantive experience in Design Controls, Product Development, developing Quality System documentation such as Quality Manuals, Policies, SOP’s, Risk Management, CAPA, Supplier Audits
Exceptional understanding of failure investigations, gap analysis, auditing, FDA & ISO inspections, remediation, company acquisitions, and Due Diligence experience
Experience in responding to the FDA on 483’s and Warning Letters
Successfully developed several quality systems for QSR and ISO 13485 compliance
Extensive International QA and auditing experience in Mexico, France, England, Sweden and Japan

L.S.D.

PECULIAR — Thu, 30 Oct 2008 17:00:37 +0000

Thirty years experience in the Pharmaceutical and high-tech Medical Device industry. Extensive knowledge of Product Development, R&D, Program Management, Quality Systems and Compliance, and Regulatory submissions.

Titles Held: Senior Vice President, Chief Scientific Officer; Principal; Senior VP Scientific Affairs; Executive Director RA/QA and Clinical Affairs; Manager, RA/QA; Senior Design Engineer

Strong validation experience in product and process validation requirements in various countries and management of the design, implementation, and documentation of validation programs for numerous (100+) products around the world
Experience with warning letters and consent decree situations with both domestic and international firms
Successfully designed, developed, and certified clean room facilities in several countries and for a wide range of products
Qualified in conducting clinical trials for IDEs and PMAs as well as clinical evaluations for market penetration purposes
Experience with all device classes:lasers (Surgical and Ophthalmic), to implants (Orthopedic and Ophthalmic), to a wide range of electronic products, disposables, IVDs, and biologics (homologous bone grafts)

D.J.C.

PECULIAR — Thu, 30 Oct 2008 14:43:41 +0000

ASQ professional with twenty-two years of experience in regulatory compliance, project management and business process improvement. Industry experience in drugs, biologics, medical devices, IVDs, and tissue banking.

Titles Held: Director of QA/RA; Principal; Corporate Director of Quality /Regulatory; QA/RA Specialist; Project Coordinator, Manager of Clinical Services

Proven capability to accomplish results in different countries and varied business functions
Strong FDA applications for Biologics IND Phase O to III; FDA applications for medical devices and IVDs, IDE’s through PMA’s
Experience with Quality programs, Design Control, SOPs, Assessments, Validation and CAPA’s
US, EU, and CE Marking medical devices and diagnostics; EU and ISO quality management audits
Experienced Auditor with QSR, EU, GC; prepared and received accreditation in EU GMP, QSR, ISO 13485, ISO 9001

E.C.W.

PECULIAR — Sat, 25 Oct 2008 15:44:14 +0000

Thirty year veteran in the medical device arena, including thirteen years working for the FDA as engineer/field investigator and supervisor specializing in medical devices. Has worked with a wide range of FDA and international requirements while solving regulatory compliance issues and improving quality systems.

Titles Held: Director of Quality Assurance; Manager of Regulatory Compliance; Manager of Quality Assurance Engineering; Associate Manager of QA Engineering

Well experienced in FDA issues including remediation of FDA-483 observations, warning letters, recalls, and consent decrees
Has conducted medical device quality system compliance (QSR and/or ISO 13485) audits in Canada, China, Puerto Rico, Ireland, England, Germany, EU, and Mexico
Resolved large backlog of medical device complaints, risk analysis, and investigations
Managed remediation programs and resolved non-compliance issues leading to ISO certification and PMA & 510k approvals
Experienced with multi-facility corporate quality assurance and regulatory compliance programs