Senior Director

JEFF RYBERG

***** *** ** ********, *****, California 92064

858-***-**** ~ ***********@*****.***

Senior Director

Quality and Regulatory

“Jeff took us from a motorcycle gang to a marching band with scalable processes.”

Dirk Soenksen

Chief Executive Officer-Aperio Technologies

QUALIFICATIONS PROFILE

Experienced and self-driven professional with 25 years of progressive background in overseeing and executing quality and regulatory compliance initiatives in high growth medical device companies. Exemplified advanced expertise in applying quality tools with verifiable record of success in developing and implementing industry directives to ensure quality and service excellence. Results-based expertise in strategy execution combined with skills in leading and managing organizational quality and compliance. Equipped with superior interpersonal skills; competent at working efficiently in both individual and collaborative environment while maintaining high quality work performance. Recognized for developing a healthy quality culture distinctively suited for an organization.

NOTABLE ACCOMPLISHMENTS

- Ensured complete implementation of quality management systems that resulted in full compliance with all customer and regulatory requirements without any non-conformance issued for initial and subsequent audits

- Successfully minimized external failure rates by more than 10% in less than one year

- Commended by Federal, State FDB, ISO, and customer auditors for the efficient design and documentation of quality management systems with particular emphasis on design control, CAPAs, and management review

- Thrived in receiving clearance for 510(k) submissions: K071128, K071671, K073777, K080254, K080654

- Implemented a fully compliant medical device design and manufacturing quality management system into an existing global operation

- Obtained certification as ISO 13485:2003 Lead Internal Auditor, CQE, CQA, RAC

CAREER OVERVIEW

- Provided proactive leadership in overseeing and implementing all quality, regulatory, and clinical functions as well as all facets of corporate compliance program

- Designed and executed annual domestic and international quality and regulatory strategies for multiple sites; presented metrics and reports to Executive Council and Board of Directors

- Administered and resolved manufacturing and global regulatory issues

- Directed all efforts to continually improve and implement quality management and regulatory systems for various-sized medical device manufacturers as well as elements of the quality systems, including design development, document control, audit programs, CAPA systems, validation, and GXP compliance processes

- Functioned as corporate representative for quality and regulatory functions during all phases of product development and developed associated quality and regulatory deliverables

- Recognized as principal liaison and management representative for all interactions with Food and Drug Administration (FDA), California Department of Public Health (CDPH), International Organization for Standardization (ISO), and other regulatory agencies

- Assumed full responsibility in ensuring complete conformity with customer and regulatory requirements, including quality system regulations (21 CFR 820), ISO 13485:2003, MDD 93/42/EEC, IVDD

- Incorporated safety risk management efforts in accordance with ISO 14971:2007 requirements

- Established strong workforce through recruiting and developing highly competitive quality, regulatory, and compliance staff in support of company objectives

WORK CHRONOLOGY

Senior Director of Quality and Regulatory

Aperio Technologies ~ Vista, CA July 2006-Present

Director of Quality Assurance and Compliance

REVA Medical Corporation ~ San Diego, CA Dec 2001-June 2006

Quality Manager

Quidel Corporation ~ San Diego, CA May 1999-Dec 2001

Director of Operations

Codeline Corporation ~ Escondido, CA May 1996-Apr 1999

Quality System Senior Manager

U.S. Medical Instruments, Inc. ~ San Diego, CA Jan 1995-May 1996

Corporate Quality Assurance Manager

Baker Equipment Engineering Corporation ~ Richmond, VA Oct 1991-Dec 1994

Quality Manager

IMED Corporation ~ San Diego, CA Mar 1981-June 1991

EDUCATION

Bachelor of Science in Business Management (GPA: 3.83), University of Phoenix ~ San Diego, CA ~ 2008

PROFESSIONAL DEVELOPMENT

ISO 14971:2007 Risk Management Training

Design and Process Failure Modes Effects and Criticality Assessment

ISO 13485:2003 Lead Quality Management System Auditor Training

Design Control for Medical Devices

510K and PMA Submissions for Regulatory Professionals

Kaizen for Manufacturing, Service and Administration

Statistical Process Control

AFFILIATIONS

Senior Member, American Society for Quality (ASQ)

Member, Regulatory Affairs Professionals Society (RAPS)

Member, AdvaMed

CERTIFICATIONS

Certified Quality Engineer (CQE), American Society for Quality (ASQ)

Certified Quality Auditor (CQA), American Society for Quality (ASQ)

Regulatory Affairs Certified (RAC), Regulatory Affairs Professionals Society (RAP)

TECHNICAL ACUMEN

Proficient with MS Office applications (Word, Excel, Project, PowerPoint, and Access)

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