Under general direction of Compliance & Audit management, the Compliance Specialist has the responsibility and authority to lead activities to investigate and understand high level product quality issues and quality management system (QMS) compliance issues, lead activities for understanding root cause of said issues, lead activities to determine applicable corrective and preventive action(s) (CAPA), identification of actions to verify or validation CAPA effectiveness, and to document these activities.
BASIC QUALIFICATIONS
·Responsibility for determination of a Quality Council and/or Quality Board for high level product quality issues stemming from customer complaints or internally discovered.
·Responsibility for documenting Quality Council and Quality Board events using the DMAIC (Define, Measure, Analyze, Improve and Check) process and form. Responsibility for ensuring timely (within 30 days of the issue discovery) documentation and completion of the DMAIC form.
·Responsibility for working with applicable QMS process owners related audit findings, non-compliances, or opportunities for improvement (OFIs) to investigate and understand the noted audit issues, for understanding root cause of said issues, to determine applicable corrective and preventive action(s) (CAPA), identification of actions to verify or validation CAPA effectiveness, and to document these activities via the DMAIC form.
·Lead kaizens as deemed appropriate or when requested for the completion of audit related issues.
·Provide expertise and guidance in the DMAIC process, identification to true root cause, identification of applicable and holistic CAPA and appropriate CAPA effectiveness utilizing Risk Management practices.
Desired/Preferred Qualifications
·Seasoned and expert experience in the medical device or pharmaceutical (FDA regulated) industry relating to regulatory compliance expectations relating to problem investigation, root cause analysis and CAPA identification and effectiveness verification or validation.
·Quality system experience to FDA and other regulatory requirements (i.e. 21 CFR 820, 803, 806, 814, ISO 13485, European Medical Device Directive, CMDCAS, PAL/Japan GMP, and relevant standards, etc).
·Experience in leading projects and/or task teams in quality, regulatory & clinical arenas.
·Exceptional interpersonal and negotiation skills and ability to cultivate positive relationships with co-workers in a cross functional and cross facility environment.
Please visit www.medtronic.com/careers (Requisition# 71269) for a full job description and to submit your profile. Please list the source as Employee Referral and 'LISA KARAS' as referring employee
Lisa Karas
Talent Acquisition | Surgical Technologies | Medtronic, Inc.
