RCM Technologies Quality Systems Engineer in Bedford, Massachusetts

Reference # :17-00438Title :Quality Systems EngineerLocation :Bedford, MAPosition Type :ContractExperience Level :Start Date / End Date :04/24/2017 / 07/24/2017 Description

Title of Position: Quality Management Systems EngineerPosition Summary:Maintains support functions and programs for worldwide compliance issues to meet domestic and international (China, Brazil, UK, etc) regulatory requirements for product quality and commercialization. The main focus of this position is to maintain and monitor key Quality Systems. Duties may include CAPA, internal Audits, Training Coordination, Supplier Audits. Procedure development, key metric reporting and other key project support under the supervision of the Quality System Manager.Key Accountabilities:

  • Oversight, training and maintenance of the CAPA program, acting as the primary liaison with different functional groups to ensure appropriate usage of the program

  • Performs data entry and prepare reports/graphs related to special projects, CAPA, Internal Audits, Training, Supplier Audits, etc.

  • Maintains accurate documentation and files related to responsibilities and special projects.

  • Participates as auditor for the internal audit program at Clients Local facility and supplier audits

  • Coordinates the site training program to ensure that new personnel are trained to the cGMP and ISO requirements specific to their job responsibilities. Reviews existing personnel base for additional training needs due to changes in the internal documents and worldwide regulatory and quality regulations.

  • Assist w/ compliance, certification,, audit documentation, reports and maintenance

  • Support activities related to the harmonization of Multiple sites Quality Systems (2 sites).

  • Processes mapping and quality system development to support continuous improvement

  • Additional responsibilities to support the Quality System as assigned.

Skills and Capabilities:

  • Strong attention to detail and accuracy, organizational, communication, analytical and technical writing skills

  • Proficiency with standard software (Word, Excel, PowerPoint, Project, etc.) experience with SAP or database development is a plus

  • Excellent written and oral communication skills with ability to interact at all levels

Minimum Knowledge & Experience required for the position:

  • BS Degree, preferably in an engineer/scientific/computer systems/or quality management curriculum or equivalent experience; ASQ CQE and CBA/CQA preferred

  • Minimum of 5 years of experience in a Quality System/Compliance role in the Medical Device or Pharma Industry

  • Working knowledge of Quality Systems Regulations (FDA QSR 21 Part 820) ISO 9001 and ISO 13485

  • Certified Auditor/Auditing experience (Internal/supplier) required.