Sr Specialist, Quality Systems
Tewksbury, MA 01810 US
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Title: Sr Specialist, Quality Systems
Hiring Organization: Connexion Systems & Engineering
- Duration: PERM
- Pay rate: $110-140k
- Job Location: Tewksbury, MA
- Job# 16219
ESSENTIAL FUNCTIONS INCLUDE BUT ARE NOT LIMITED TO:
- Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.
- Evaluate, trend and triage issues that may be considered Corrective and Preventive Action (CAPAs).
- Facilitate product and process CAPA investigations from issue identification through implementation of solution and effectiveness monitoring.
- Facilitates NCMR trending & CAPA Review Board (CAB) meetings.
- Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
- Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and identify opportunities for improvement.
- Lead and mentor cross-functional teams with the implementation of appropriate root cause analysis techniques
- Data Analytics (KPI): Leverage analytical tools to deliver solutions that help solve business problems (Power BI, SharePoint Online, Excel, etc.). Deliver ongoing reporting & analytics of KPIs to the SR Leadership Team and for CAB meetings.
BACKGROUND AND QUALIFICATIONS:
- Minimum of 8 years’ experience in a Manufacturing Quality and/or Quality Systems role, with 4 years’ responsibility for Product Quality and/or Quality Systems.
- Working knowledge of Medical Device Regulations: FDA 21 CFR 820, ISO 14971 & 13485 as well other applicable regulations and industry standards pertaining to Medical Devices.
- Functional knowledge & experience of effective root cause investigation, corrective and preventive action planning, execution, and verification of effectiveness techniques. Experience with quality tools and process improvement techniques.
- Experience with manufacturing of complex products in an Environmentally controlled area. Experience with medical capital equipment and electromechanical devices preferred.
- Utilization of statistical data analysis for trending purposes; ideally Six Sigma methods and tools
- Ability to communicate ideas and information clearly, effectively, and concisely.
EDUCATION: BS in Mechanical, Electrical, or Biomedical Engineering or other scientific or related discipline.
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