Responsible for supporting all Philips medical device manufacturers (Precision Diagnosis, Connected Care, Image Guided Therapy, Personal Health, etc.), markets, and functions in their adoption of the enterprise CAPA process.• Drive standardized and compliant investigation practices through high-engagement and positive change management.• Upskill the organization through formal training, active knowledge sharing, mentoring, and coaching.• Deliver comprehensive, 4-day classroom technical training for CAPA concepts including root cause analysis to over 300 attendees to date with a 4.8 average rating. • Support problem solving of high-risk product and process failure investigations.• Perform independent review and approval of investigations and closures to ensure quality standards are met.

Managed 5 training administrators supporting 6K employees. Led continuous improvement initiatives resulting in €1.5M in cost savings YTD in 2021. Supported business to market integrations and quality transitions. Monitored quality objectives and prepared management review. Performed internal QMS audits to ISO9001:2015 and ISO13485:2016.

Managed 20 complaint evaluators across multiple product lines. Led remediation of 225K aged complaints in 2019. Remediation was recognized as a finalist in the 2020 Excellence Competition out of 700 projects globally. Led process improvement initiatives including CAPAs to improve the complaint handling process.

Led a team of 10 CAPA Facilitators. Recognized by the business as a subject matter expert. Mentored CAPA Facilitators and Investigation Owners. Reviewed and approved all active investigations (average of 60 investigations per month). Represented CAPA and provided responses during internal and external audits including the FDA. Ran CAPA daily management with CAPA Facilitators and weekly management meetings with executive leaders.

Facilitated cross functional root cause analysis of product and quality system non-conformances using sound root cause methodology such as Ishikawa diagrams, Is Is-Not, Timeline, or 5 Whys Analysis. Thoroughly documented investigations and developed appropriate corrective action based on risk. Presented reports and plans to quality and upper management for review and approval. Measured effectiveness of implemented corrective actions. Tracked investigation deliverables.

Investigated and recommended corrective action to address product and quality system non-conformances including FDA Form 483 observations. Facilitated up to 20 investigations at one time. Remediated investigations and action plans to meet Consent Decree commitments to the FDA.

Participated in remediation of Hazard Analysis and Failure Mode Effects Analysis Risk Management reports to meet Consent Decree Work Plan commitment to the FDA. Participated in periodic review of Risk Management documents to ensure compliance to regulations and standards. Tracked and provided metrics for quarterly Quality Management Review.

Supervised store opening and closing procedures and managed 15 front-end associates.

Researched medical device manufacturers, assessed medical device cost, and participated in medical device trials to support purchase evaluations.