Steve Westgate Email & Phone Number

Norwood, Massachusetts, United States

Expertly led a team of Quality Assurance specialists providing direct support to manufacturing personnel. Ensured consistent and intentional professional development through coordinated training and upheld internal, industry and national compliance standards through diligent analysis and reporting.

Cambridge, Ma

Responsible for the internal review process of raw medical materials and verifying compliance standards are upheld. Through initiative and industry experience, initiated the review and implementation of corporate standard operating procedures to modernize QA operations. Led batch record review efforts for the QA department. Sought after by senior executives for insight into current priorities for QA department.

Allston

Frequently relied upon by senior leadership and peers as interim supervisor. Experienced in reviewing batch records, and deviation analysis. Conducted deviation analysis and audited manufacturing processes and procedures for safety and efficiency. Served as a compliance coach for external organizations and became an internally qualified trainer.

Cambridge

Experienced in conducting and leading product investigations. Tracked patient and vendor correspondence for compliance and privacy record keeping. Effectively managed the handling of compliance issues and coordinated with QA team members and external parties for collaboration on complex compliance matters.

Conducted routine volume, vacuum, leakage, tensile and dimensional assessments of medical equipment such as chest drainage systems and sutures. Tracked compliance failure modes and critical investigation results via SPC. Coordinated with manufacturing and engineering teams to assess the root cause of failure and remediation plans. Wrote SOP change requests and submitted to senior management for review and approval.

Led weekly meetings with out-of-state facilities regarding product compliance and deviations. Responsible for training quality assurance analysts on corporate compliance processes, including cGMPs within Trackwise. Reviewed compliance investigations for adequate and accurate details and provided recommendations accordingly. Initiated communications with charge nurses and doctors for additional compliance data. Reviewed FMEA and technical files in support of MDR decisions. Created and submitted FDA MedWatch reports in accordance in accordance with federal regulations. Engaged with the Medical Director for complex compliance issues. Ensured 100% corporate compliance with all quality system procedures, cGMPs (U.S. and European) as well as FDA requirements.