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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.
- 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
- 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.
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