Connexion Systems & Engineering, a Boston based IT and Engineering Solutions Company immediately seeks individuals with the following skills:
Date Posted: 5/3/2019
Hiring Organization: Connexion Systems & Engineering
Job Title: Quality Systems Coordinator
Location: Waltham, MA 02454
Employment Type: Full Time, Contract to Permanent
Pay Range: 30-35/hr. or 65-70K
Duration: Contract to Permanent
Quality Systems Coordinator
MUST have experience with Electronic Records Management
The Training and Quality System Coordinator will participate in building up the training program and processes. The Coordinator will also help drive improvements in other areas of the quality system such as Change Control, CAPA and Non-Conformance.
- Planning, organizing and supporting the overall quality system and training program
- Developing and tracking metrics to achieve business goals and KPIs for the Quality System
- Developing and monitoring a means for measuring and improving training and effectiveness
- Act as a resource when developing training plans
- Support the Document Control team on an as needed basis
- Distribute training requirements for newly hired employees and for change orders
- Participate in compliance activities, such as CAPAs, non-conformances and support internal/external regulatory audits
- Develop and maintain Quality metrics and dashboards
- Minimum 3-5 years working in a regulated environment, preferably in the medical devices or pharmaceutical industries
- Minimum 3 years’ experience in coordinating, developing and documenting training related subjects
- Minimum 2-3 years’ experience in other areas of Quality Management Systems such as CAPA and Non-Conformance
- Experience with Quality Management System (ISO 13485) and Medical Device Regulations (21 CFR 820)
- Self-motivated, able to accomplish multiple assignments simultaneously.
- Strong organizational and problem solving skills.
- Demonstrated competency in computer skills: MS office applications, query tools, and enterprise database systems.
- Must be able to communicate appropriately and adequately to all management levels, including group presentation experience.
- Demonstrated experience/results in Quality System tools and problem solving.
- Proficient computer skills, including Excel
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ConneXion Systems & Engineering
490 Boston Post Road
Sudbury, MA 01776