Title: Quality CAPA Analyst

Location: Princeton, NJ (REMOTE)

Schedule: Mon - Fri, 8:30am - 4:30pm - Full Time

Type: Contract - Full time

Start Date: ASAP

Responsibilities:

• Assists with daily operational aspects of the NC/CAPA Process
• Collaborates with the Quality management team to review and finalize monthly and quarterly NC/CAPA metrics. Run ad hoc reports as necessary
• Participates in global site NC/CAPA continuous improvement workshops.
• Develops and provides general training to the global NC/CAPA team and other applicable users as necessary. Will also facilitate training when changes are made to the process and procedure.
• Assists/supports sites with event management and processing as needed.
• Assists as a NC/CAPA subject matter expert in audits as necessary.
• Assist in Corporate and local site CAPA Review Board meetings.
• Identify and assist with the implementation of updates to the NC/CAPA program
• General Quality Management System Support
• Assists in the preparation and execution of site Management Review meetings.
• Assist in any administrative duties for the Quality Management System team as needed.

• The Global CAPA/Metrics Analyst is responsible for reviewing and analyzing data from the global event management system, including but not limited to, non-conformances and CAPA for any trends across sites. He/she will be responsible for compiling data for weekly and monthly reports using both the Agile system and the Power BI dashboard. MUST be strongly proficient in MS Excel and have ability to utilize Excel fundamentals to report trending and organize / display data.

  
  

Requirements:

• Minimum of bachelor’s degree in a science or mathematics field from an accredited institution
• 2-4 years of experience in Medical Device/ CAPA process per 21 CFR820.100 and ISO 13485

• Excellent interpersonal skills – ability to build positive relationships at all levels both internal and external to the organization
• Excellent communications skills – ability to communicate clearly and concisely in multiple media – verbal, written, etc.
• Excellent organizational/time management skills.
• Strong Analytical and Statistical Skills
• Ability to work independently and be detail oriented
• Ability to interpret and analyze technical data
• Personal computer efficiency required (TEAMS, word, Excel, Power Point, and Power BI)
• Ability to create reports and trend data utilizing Microsoft tools such as excel, Power BI.
• Power BI not a requirement but strong plus!
• Maintains strong knowledge of medical device standards / regulation (Global cGMPs, US, MDSAP, ISO 13485:2016, Europe & ROW)

Joule, a System One division, is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices througough the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delviered workforce solutions and integrated services to clients nationally.