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Quality Assurance - Doc Control Specialist

Job Description Summary:

Support and maintain quality compliance and elements of the Quality Management System. The role

requires cross-functional project management skills and the ability to influence across the

organization to drive compliance activities.

Responsible for all aspects of document control. Responsible for the management of quality systems

and practices. Reviews and accepts incoming and in-process materials through the review of quality

records assuring the materials meet specified requirements. Assures activities at EMS remain in

compliance with applicable federal and state regulations, international standards, and the company’s

Quality Policy.

 

Position Responsibilities and Authorities:

  • Supports and ensures compliance of the company quality system with US and OUS regulatory requirements. Assists in the maintenance of the quality management system.

  • Initiate and lead quality and reliability improvement activities for internal processes.

  • Maintains procedures to ensure that the appropriate checks and balances are included to ensure a quality output.

  • Initiates and organize best practice activities aimed at the continuous improvement of QMS practices through a team approach.

  • Performs and assigns tasks within QA to ensure QMS objectives are achieved in a timely manner.

  • Manages the document control system in accordance with the quality system requirements

  • Coordinate and/or provides training to employees for GMP/ISO and quality system procedures.

  • Maintains current training record files for all employees

  • Coordinates and maintains QA receiving inspection process and procedures and reviews records for compliance.

  • Maintains in-process quality inspection process and procedures and reviews records for compliance.

  • Maintains Nonconforming Material process and records.

  • Maintains Supplier Qualification process and records.

  • Maintains Equipment Management process and records.

  • Other duties as assigned

 

​Qualification Requirements:

Education: Associate degree or equivalent experience.

 

Experience & Skills:

  • Minimum of 2 years of experience working in medical device industry, preferably in Electromechanical device industry.

  • Strong computer skills (MS Word, MS Excel, Solidworks is a plus).

  •  Dynamic leadership and interpersonal skills.

  • Experience in working with manufacturing/operations and engineering in medical device preferred.

  • Works well under pressure, organized and self-motivated.

  • Experience in a small company environment.

  • Ability to work independently or in a team setting.

  • Knowledge of and exposure to product inspection, data collection and product testing.

  • Familiar with design control procedures and requirements.

  • Solid knowledge and interpretation of applicable regulations, guidelines and policy statements (QSR, MDD, CMDR, and ISO).

To apply for this position, please submit your resume via email to jobs@energymedsystems.com