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12481
PERM

Quality Systems Specialist

Location: Providence RI, Rhode Island

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

Title: Quality Systems Specialist

Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

  • Duration – Permanent
  • Pay rate:  $90-95K.
  • Job Location:  Providence, RI
  • Job#: bh12481

Quality Systems Specialist


Position: The Quality Systems Specialist provides company leadership in the maintenance and improvement of corporate-wide quality management systems and support processes. S/he proactively manages the various elements of the quality system to ensure compliance to applicable national and international quality system regulations. This position also performs cleanroom monitoring, maintains QSR/ISO 13485 Quality Systems compliance, executes Preventive Maintenance, and equipment control processes. This position reports to the Director of Quality Systems.

Responsibilities:

  • Support the Quality Systems Department by providing hands-on ownership for the various elements of our Quality Management System including corrective and preventive action (CAPA), and/or internal audits etc.
  • Ensure timely closure of Audit Findings and Continual Improvement Items.
  • Ability to support monthly operations meetings by compiling and presenting metrics.
  • Primary responsibility to perform the routine monitoring of the cleanrooms for nonviable particulate and viable monitoring per established procedures.
  • Complete all the documentation associated with cleanrooms, to include monitoring forms, excursion reports, and tracking and trending, at a minimum.
  • Participate in the qualification and validation activities related to cleanrooms.
  • Liaise with internal operations and external service providers, namely for cleanroom certification and preventive maintenance activities for the cleanrooms.
  • Serve as secondary (back-up) Equipment Coordinator and assist in activities such as managing equipment files, and preventive and corrective maintenance activities.
  • Support Quality Systems activities such as ownership of CAPA’s, customer complaints, audit finding, etc., as directed by the Head of Quality Systems.
  • Compile and track appropriate metrics and data to demonstrate Quality Management System Compliance, as directed by the Head of Quality Systems.
  • Other responsibilities as signed by direct supervisor

Requirements:

  • Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Project Management, clients, and customers
  • Investigational and communication skills
  • Strong attention to detail
  • Demonstrated working knowledge of Quality Management Systems requirements, preferred
  • Flexibility to multi-task and perform a wide range of activities
  • Excellent computer skills, including MS Office proficiency and document control software
  • Medical device GMPs, ISO 13485, MDD 93/42, Technical files, and QSR requirements for documentation

Education: Bachelors’ Degree or higher in an Engineering discipline or equivalent experience.

Experience: Minimum of 3 year’s relevant experience in Quality Systems and Quality Control in a new product development, medical device, environment.

Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you immediately.

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