Job Title: Quality Engineer (CAPA)
Openings: 2
Duration: 1 Year Contract
Location: Preference of Local to Cambridge, MA to be in office 80% of the time
- 222 Jacobs Street, Cambridge, MA 02141
- If not Cambridge, then 1010 Murry Ride Dr. Pittsburgh PA
PR: $40-50/HR
Interviews Process: 1 and Done Interview with Manager
Job Description:
Insight Global is seeking a SME in Corrective and Preventative Actions (CAPA) to analyze and advise involved teams throughout the various end-to-end CAPA investigation processes. The responsibilities of this person will be as follows:
- Complete product and process CAPA review tasks such as identifying issue descriptions, reviewing data, facilitating root cause analysis, advising on solutions, implementing solutions, and effective monitoring of the product post-CAPA
- Initiative CAPA investigations and advise on solutions to cross-functional teams
- Manage CAPA activities across all cross-function teams, including scheduling CAPA team meetings, ensuring the deliverable timeline will be met, ensuring effective monitoring post analysis, represent the CAPAs during audits and Review Board meetings, and mentoring the team throughout the analysis process
- Confidently work in a high-pressure environment while delivering on multiple projects with urgency
Must Haves:
-Bachelor's in engineering or related field
- 3-5+ years practical experience with CAPA - medical device industry preferred
- Root cause analysis methodologies, statistical sampling for effectiveness
- Owning CAPA processes from start to finish
- Strong understanding of appropriate global regulations and Quality Management Systems such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971
-Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels
Plusses:
- Medical device industry experience
- Experience with Trackwise
- Project Manager background, especially over CAPA activities