Responsible for leading a structured, site-wide approach to document

control, records and training for the Tecomet. Includes continuous

assessment of employee development needs for all positions, as well as

the development, implementation, and evaluation of training

effectiveness to align with business strategy. Develop, coordinate,

implement, and communicate the training initiatives and document control

and records to ensure compliance to FDA, Global Regulatory bodies and

ISO requirements. Training includes but is not limited to quality

control, work measurement, manufacturing methods, and

supervisory/management development. Manage the document system and

records to ensure documentation procedures are maintained based on

FDA/ISO And Corporate Standards And Regulations. ESSENTIAL FUNCTIONS

Coordinates the document control system to meet and maintain FDA/ISO,

Corporate standards, and customer requirements. Oversees the change

control process for product and process related information, providing

records and information management services to various departments.

Coordinates the overall direction for the creation and updates of

product and process-related data in accordance with internal procedures,

FDA regulations, and ISO requirements. Supports internal and external

audit activities through retrieval and provision of requested document

and data elements in a timely matter. May act as subject matter expert

related to Records and Information Management activities, interfacing

with auditors as required. Continuously improves current business and

system processes by creating, redefining, and maintaining standard

company procedures to ensure maximum efficiency in business and system

processes. Seeks input on improved strategies and processes to help

achieve goals. Implement new processes and system practices to achieve

the goals. Responsible for the organization, maintenance and storage of

all documents related to FDA/ISO compliance, DMRs, DHRs, DCNs, and

Management Review Records. Maintains established metrics and achieve

goals for the document control system, including open change requests,

training courses Researches, plans, organizes, and supports the needs of

Tecomet?s training programs through coordination, instruction and

monitoring/measurement of effectiveness. This includes all Quality

System required training programs. Coordinates the electronic training

module to ensure timely closure of training assignment and courses.

Conducts on-going assessments of Tecomet?s employee training filed to

ensure compliance to position requirements. Collaborates with

management, supervisors, and employees to gain knowledge of work

situations requiring training and to better understand changes in

policies, procedures, regulations, business initiatives and

technologies. Designs, conducts and drives training orientation, and

track and report on progress of employees under guidance during training

periods (i.e. QSRs, JTAs). Maintains employee training records and

matrix and reports training information as subject matter expert to

internal and external customers/auditors upon request. Researches,

designs, develops, or selects training programs and establishes measures

of effectiveness; reviews, evaluates, and modifies existing and proposed

programs and recommends appropriate changes. Provide organizational

assessments, metrics and analysis as it pertains to document control,

records, change control and training to upper management. Supports

Tecomet?s Worldwide Quality Management Systems Software

implementation/validation and harmonization (ETQ); New Product

Development; and Supplier Quality Systems. May supervise or oversee

Other Document Control Personnel. Additional Functions And Requirements

may be assigned by supervisors/managers as necessary. KNOWLEDGE, SKILLS

AND ABILITIES: Strong organizational skills Strong people and leadership

skills Diplomacy Motivation Teaching/Coaching/Men oring