Duties and Responsibilities:

• Is the company Management Representative responsible for implementing,

establishing, and maintaining the company quality system in accordance with ISO13485
/ 21CFR820 and other specifications as required, ensures the company meets any other
additional customer specific requirements. Represents the company as the liaison with
external parties regarding the company quality system and its" capabilities.

• Responsible to facilitate management review meetings and report on the performance

of the quality system and its" metrics.

• Is a certified Lead Auditor responsible for the company internal audit program in

compliance with ISO13485 / 21CFR820 and other specifications as required. Conducts
QMS, Process and Final Product Audits.

• Manage Internal Corrective Actions (ICAR): manage log, issue ICARS, assist in corrective

actions and verify effectiveness of corrective actions through auditing.

• Interfaces with customers, sales, manufacturing, and engineering to resolve quality and

contractual issues.

• Manages the corrective action process in molding, including facilitating and leading

corrective action teams, maintains dialogue and correspondence with customers and
suppliers, controls records regarding corrective actions. Assists and facilitates corrective
action teams in stamping upon request.

• Facilitates company quality system related training programs, gives on the job

instruction and presentations as needed. Coordinates diverse training needs with
outside consultants. Obtains outside funding for training (NJ Customized Training) as
needed.
Qualifications:

• 5 years" experience in Quality Control/Assurance in a tight tolerance industry with a

medical device or life sciences customer base.

• Needs a thorough understanding of automotive and medical industry quality

requirements (APQP, FMEA, Process Flows, Control Plans, Measurement System
Analysis).

• Requires training in and thorough understanding of ISO13485 / 21CFR820.
• Maintains and is responsible for the company"s document control system. Responsible

for the maintenance of the Master Databases on the company network used to control
company documents.

• Maintains and controls the company ISO13485 / 21CFR820 Training records for all

company team members. Responsible for the maintenance of Master training
databases on the company network.