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Posted: Tuesday, June 13, 2017 11:51 AM

Job Description:/h3:
Senior CAPA Analyst(Contract Opportunity)
Facilitate CAPA process and related activities. Create CAPAs; monitor and analyze data and trending. Lead and/or support activities for process improvements and systems integration projects.
Responsibilities:
:5+ years experience addressing Corrective Actions in a regulated industry
:Demonstrated knowledge of Quality Management System requirements: FDA Medical Device regulations (QSR) requirements, ISO 9001 / 13485, and applicable Medical Device Directives
:Demonstrated ability to use Word, Excel, Visio, and Microsoft Project
:Demonstrated ability to effectively apply problem solving techniques
:Demonstrated ability to effectively facilitate meetings to determine root cause investigations and analysis
:Demonstrated ability to work with electronic systems to complete/evaluate data analysis, trending, and system configuration
:Demonstrated ability to collaborate with individuals across multiple plants/locations
:Demonstrated ability to manage projects
:Lead and participate in CAPA process and system improvements.
:Ensure CAPA activities are effectively coordinated across all plants/locations.
:
Facilitate/participate in CAPA review meetings.
:Ensure compliance to the Divisional CAPA process requirements across all plants.
:Perform trending activities.
:Maintain divisional metrics.
:Communicate CAPA data and information to management.
:Provide information, as appropriate, to feed into the corporate CAPA process.
:Support the company Orthopaedics continuous improvement initiatives.
:Lead and participate in projects related to system integration and improvements to the electronic CAPA data system as it relates to CAPA.
:Perform system administration activities in the electronic CAPA data system.
:Perform and participate in divisional training on systems and/or processes related to CAPA system.
:Actively promote a team approach to the CAPA process across all departments and all plants.
Qualifications:
:Bachelors Degree in Business, Engineering Science or related field of study. Prefer formal problem solving techniques training and/or certification.

LS




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Company Description:/h3:
Comrise is the bridge to first:rate talent for organizations that recognize the value of their workforce. With locations in the U.S., China, and Hong Kong, we help our clients reach far and wide for both local and international resources which yield the highest return on their human capital investments.Headquartered in New Jersey since 1984, Comrise is a staffing, consulting and enhanced search technology company. For over 30 years we have delighted our clients and consultants by focusing on customer satisfaction, innovation and flexible workforce solutions.By combining our global networks with our outstanding local offices, Comrise provides high quality executive search, temporary and temporary to permanent staffing solutions, and cross border placement services.

Source: https://www.tiptopjob.com/jobs/68270388_job.asp?source=backpage


• Location: mahwah, North Jersey

• Post ID: 38116133 newjersey
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