Kerry Chase Email & Phone Number

Bedford, MA, US

Bedford, Massachusetts, United States

A Certified Manager of Quality/Organizational Excellence facilitates and leads team efforts to establish and monitor customer/supplier relations, supports strategic planning and deployment initiatives, and helps develop measurement systems to determine organizational improvement. CMQ/OE will be able to motivate and evaluate staff, manage projects and human.

Bedford, Massachusetts, United States

This certification program has a comprehensive curriculum covering all relevant modalities within the regulatory lifecycle of a medical device. With the expectation of enhancing my skills as a Quality leader in the medical device industry. Estimated completion of course work is January 2025. RAC exam estimated March 2025.

Boston, Massachusetts, United States

• Built a five-member team responsible for global post-market quality (PMQ) in development, implementation, and management of post-market and post-analytical duties related to quality management system (QMS) regulatory.
• Met device and laboratory regulations and standards (21 CFR 820, 803, 806, EU IVDR, ISO 13485, ISO 14971, ISO 15189, CLIA, and CAP) by implementing complaint management processes.
• Developed risk-based issue assessments for escalation of internal and external reported incidents (ISO 14971 and health hazard evaluations).
• Chaired and led the monthly quality safety review board attended by senior and executive leaders, presenting post-market data analytics and trending data results.
• Completed successful IVDR audit for the post-market function by establishing IVDR-compliant processes (PMSP, PMSR, and PSUR).
• Implemented companywide complaint training focused on identification, documentation, and escalation for required investigation.

Cambridge, MA

• Promoted to lead multiple post-market operations teams of more than 40 members conducting customer feedback and field service triage, complaint investigation, regulatory communication, adverse event reporting.
• Implemented and standardized post-market operational processes across the business unit, including regulatory communication, 806 submissions, and adverse event reporting.
• Instituted a field action review board (FARB) for business leader evaluation of safety and non-safety issues impacting patients and products.
• Provided leadership development and mentoring to post-market program managers on reviewing complex issues and executing corrective action.
• Served as a primary lead and post-market subject matter expert during inspections and internal and external audits.
• Designated as main liaison with global regulators and key markets on recalls (FSN and FSCA) and incident reporting (MDR and MIR).

Andover, Massachusetts, United States

• Led post-market managers supporting business units in development and submission of reportable incidents and recalls (FSCA) to regulators. Reviewed and communicated recall and FSCA submissions prepared by post-market.
• Served as CAPA owner, driving post-market corrective actions and preventive actions in root cause analysis and effectivity checks.
• Directed a team of ten business adverse event coordinators on incident reporting to meet global reporting timelines.
• Led as post-market expert supporting successful interface validation of eMDR submissions between the business complaint system (Trackwise) and the FDA MDR database.

Andover, Massachusetts, United States

• Collaborated within the business unit to develop comprehensive field action deliverables for submission to regulators. Managed end-to-end deliverables for business safety and compliance field actions.
• Served as a post-market representative for key initiatives and a subject matter expert supporting inspections as well as internal and external audits.

Burlington, Massachusetts, United States

• Established quality management system (QMS) procedures and processes for the startup organization.
• Conducted annual sitewide quality training and quality orientation for new employees. Performed quality reviews and approvals on all change requests.
• Developed complaint management, CAPA, and internal audit processes for emerging medical device products.

Bedford, Massachusetts, United States

• Led the quality assurance group in development and improvement of quality process compliance.
• Managed four-member document control functional team and maintained design history files (DHF) for regulated products.
• Strategically planned site closure, ensuring certification as well as DHF and record transfer.

Boston, Massachusetts, United States

• Conducted internal auditing of all functional areas, establishing a quality systems contract research organization (CRO) business model.
• Supported on-site FDA inspection pertaining to data management as a CRO.
• Established internal processes for quality data review.

Bedford, Massachusetts, United States

• Served as product quality team member, managing design phase deliverables.
• Collaborated with R&D and program management departments for product launch approvals.
• Projected all phase deliverables for design reviews and approval gates.

Dual Rac Certification Pending, Medical Device & Pharmaceutical & Biologics

Certified Quality Auditor (Cqa)

Bachelor Of Science - Bs, Pre-Veterinary Studies/ Biology