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CAPA Quality Engineer (med device)
Job
Entegee
Somerville, MA (In Person)
$161,200 Salary, Full-Time
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Job Description
CAPA Quality Engineer (med device) Entegee - 3.7 Somerville, MA Job Details Contract $65 - $90 an hour 1 hour ago Benefits Commuter assistance Disability insurance Dental insurance Vision insurance Life insurance Qualifications Engineering Master's degree Mentoring Project scheduling FDA regulations Full Job Description Job Summary We are seeking a dedicated CAPA (Corrective and Preventive Action) Quality Engineer specializing in medical devices to join our quality assurance team. This role is pivotal in ensuring compliance with industry standards and regulatory requirements, including ISO 13485 and FDA regulations. The successful candidate will lead investigations into quality issues, develop effective CAPA plans, and drive continuous improvement initiatives across manufacturing and quality systems.
Summary:
- Responsible for leading CAPA engineering activities like: assessing complex investigations and corrective actions and reviewing test and other complex performance data, leading complex root cause analysis and complex quality problem solving.
Job Responsibilities:
- Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
- 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.
- Represent CAPAs during audits and CAPA Review Board meetings.
- Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).
- Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and