Ruderfer & Associates, Inc.
Irwin A. Ruderfer, CPC, President
25 Pompton Ave., Verona, N.J. 07044
Tel: (973)239-2000 Fax: (973)239-9080
e-mail: irwin@ruderfer.com
Position
Director of Quality Assurance and Regulatory Affairs
Company:
Atlanta, Ga
Class 1 Medical Device manufacturer located outside of
Compensation
$150K- 175K + 10% Bonus + Relocation Offered
Reports to
CEO
Our client is an FDA registered, ISO 13485.2003 certified engineering and
manufacturing outsource Service Company providing design, development and
manufacturing services to the medical device marketplace. They specialize in
developing and manufacturing hand-held devices (including reusable and
disposable components) that are precise and highly intuitive in the hands of
patients and end-users.
POSITION SUMMARY
This position is responsible for establishing strategic plans, policies, and procedures at
all levels to ensure the QA program will meet or exceed internal and external customers
needs and expectations. General responsibilities include implementation, coordination
and direction of corporate Quality Systems directly and through all activities of personnel
and equipment engaged in design, testing, regulatory compliance, auditing, CAPA and
customer complaints. Corporate quality system reflects activities in all aspects and
locations of Facet. Provides functional guidance to direct reports and implements the
vision of World-Class initiatives, continuous improvement and full compliance to all
regulating standards.
PRINCIPAL RESPONSIBILITIES include the following. Other duties may be
assigned.
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Establishes and implements Quality and regulatory strategic plans and policies.
Develops and implements methods and procedures for inspection, testing and
evaluation of products.
Develops and manages departmental operating and capital budgets
Manages all QA Engineers, Supervisors, Inspectors, Regulatory Specialists and
Technicians.
Develops staff, including mentoring, career development, intra-personal skills,
training and annual performance appraisals.
Formulates and maintains QC objectives and coordinates objectives with
manufacturing procedures in cooperation with other managers to maximize product
reliability and minimize costs
Institutes and manages continuous improvement programs throughout Facet
Plans, develops and implements departmental policies and goals
Ensures corporate wide compliance to current QSRs, ISO and EN regulations
Direct all quality related investigations, change control, and audits
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Manages all regulatory files, including DHR, MDR, CE Technical Files, 510k,
Product/Establishment Registration, etc.
 Responsible for MDR investigations/FDA reporting and EU vigilance
 Coordinates ISO 13485, MDD and JPAL/JGMP certification activities and functions.
 Acts as management representative of quality system, including official
correspondent with FDA and Sekinin-Gijutsu-Sha for JPAL requirement.
 Oversees preparation and maintenance of 510k (s) and CE Mark Technical Files
 Establishes statistical sampling procedures and record keeping systems.
PROBLEM SOLVING DECISION MAKING
 Applies comprehensive knowledge of quality assurance/regulatory requirements to
the completion of significant and difficult assignments
 Ability to be proactive in the identification and solution to business issues
 Ability to deal with quality issues proactively both tactically and strategically
 Ability to define problems, collect data, establish facts, and draw valid conclusions
ACCOUNTABILITY
 Identifies, initiates, plans, conducts, reviews, evaluates and supervises daily tasks
with minimal functional guidance
 Interprets and applies corporate policies
 Departmental budget (operating and capital)
 Strives for continual improvement in all responsible areas
 Knowledge of materials, methods, techniques, practices, tools equipment and
processes required to effectively execute tasks in manufacturing
SUPERVISORY RESPONSIBILITIES
 Quality Engineers
 Quality Engineering Supervisor
 Quality Technicians
EDUCATION
 Minimum of BS in engineering or related field
EXPERIENCE
 Minimum of 15 years related quality/regulatory management experience in a medical
device or ISO environment
 Extensive knowledge and experience with QSRs, ISO and EN regulations
 Experienced with process improvement, SPC and other statistical process
control/dock to stock methods
 Has managed new product start-ups and launches from a quality/regulatory
perspective
 Fundamental knowledge of business metrics
CERTIFICATES, LICENSES, REGISTRATIONS
 ASQ CQE or CQA
 Six Sigma experience, Black Belt certification desired