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**TITLE** : Document Control Coordinator

JOB SUMMARY:

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/Mentoring

+ Verbal and written communication and listening skills

+ Highly Proficient in Microsoft Office

+ Problem solving and evaluation

+ Process improvement

+ Project management

+ ISO 13485/EN46001, 9001

+ ISO 14001

+ AS 9100

+ Federal and State laws and regulations

+ Knowledge of International Quality Standards

+ Knowledge of International Environmental Standards

+ Strong auditing background

+ Be flexible and adapt to changes in the marketplace

+ Create and manage high performing work teams

+ Interface professionally and courteously with customers/public/internal staff

+ Prioritize work

+ Meet goals and objectives set for the company

+ Make decisions in a consistent, professional manner

+ Maximize opportunities for the business

+ Ability to read and interpret documents such as technical data, safety rules, operating and maintenance instructions, and procedure manuals.

+ Ability to write routine reports, correspondence, and presentations.

+ Ability to speak effectively in interpersonal situations and present before groups of employees at all levels.

+ Ability to track and chart metrics for areas of responsibility.

EDUCATION AND WORK EXPERIENCE:

Educational/Training Requirement:

+ Associate’s degree or Equivalent Experience preferred

+ Experience, training and certification may be considered

+ Bachelor’s degree (desirable but not essential)

Experience:

+ 5+ years of Quality Assurance experience with Document Control, Change Control and Records is preferred.

+ Experience in Technical Writing.

+ Minimum of 2 years of experience related to working within a regulated environment is preferred.

Licenses/Certifications:

+ ASQ: CBA, CQA and CQT certification, preferred.

**TRAVEL REQUIREMENTS:** Minimal

+ Travel will be determined as needed.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

While performing the duties of this job, the employee could be required to stand. The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision, and ability to adjust focus.

Equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities

**Americans with Disabilities Americans with Disabilities Act (ADA):** Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

_The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company._