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Job Information

Training & Document Control Specialist in Woburn, Massachusetts

Position Information

Job Summary:

Under the direction of the Quality Manager, maintains the Quality system as directed. The main responsibility is to maintain company compliance to the QMS per ISO requirements, with specific focus on section 6.2 human resources and section 7.5.3 identification and traceability.

The role requires the above to be accomplished within Tecomet’s principles of continuous improvement, customer-driven innovation, and a win-first culture, while meeting company financial and other performance metrics.

Essential Duties and Responsibilities:

  • Responsible for understanding the ETQ Quality Management System (QMS) and ISO 13485 requirements specific to job functions. Effectively maintains the quality system.

  • Knows and follows all safety requirements.

  • Impart company compliance in accordance with the Quality Management System and ISO 13485 requirements.

  • Implementation of all policies and record maintenance.

  • Review all documents in the ETQ system and move them to the next phase.

  • Assists in general office managerial activities

  • ECO generation, implementation, and closure

  • Administrator of training documentation for all employees.

  • Training Coordinator and Trainer of all On Boarding training.

  • Familiarization with document completion and control in accordance with the QMS.

  • Prepare Certificates of Compliance with accompanying documentation for all shipments.

  • Conduct job closing activities and lot releases.

  • Ability to work overtime as needed.

  • Performs other duties or special projects as required or as assigned by supervisor.

  • Order and maintain Industry Specifications.

Qualification Requirements

Educational/Training Requirement:

  • High School Diploma

Knowledge, Skills, and Abilities:

  • Impart on personnel daily to comply within the Quality Management System.

  • Exceptional aptitude for details.

  • Proficient with Microsoft Office products.

  • Excellent communication skills (verbal, written, presentation) with internal staff.

  • Excellent organizational skills.

  • Highly proficient in Microsoft Office

  • Excellent data entry skills

  • Excellent communication and interpersonal skills

  • Ability to work independently and exercise judgment

Other Requirements

Mental Requirements:

The work environment is representative and typical of similar jobs in comparable organizations.

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.

Americans with Disabilities Act (ADA):

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Equal Opportunity/Affirmative Action Employer/Protected/ Veterans/Disabilities/Drug Free Workplace

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.