-SQF Practitioner-Regulatory Compliance, ensuring that suppliers adhere to FDA and local regulatory requirements for food safety and quality. -Maintain accurate supplier quality records, certifications, ASL in TraceGains (platform) updated. -Conduct external audits to Suppliers.-Implementation of the SCAR program within the company.-Conduct Food Fraud vulnerability assessment (FFVA) and mitigation plan according to GFSI, FSSC 22000 standards and FDA hazard analysis requirements.

-Lead efforts for the investigation and task completion for compliance efforts. -Assist in the Root Cause investigation to improve quality failures in the Ethicon San Angelo manufacturing process. -Implementation of effective CAPA actions assigned to Business Excellent department. -Update Master Routes from San Angelo site related to CAPA action items. -Provide recommendations in troubleshooting and resolving equipment, systems, and process problems to prevent the occurrence of product and process nonconformities.-Software validation protocols and completion reports.

-Design and develop production equipment, fixtures and tests as needed to build the production line internally. -Lead, develop, and implement supplier/purchasing controls. -Manage detailed projects of design transfers internally and/or externally by leading efforts with little guidance/mentoring from management. -Sustain supply chain continuity by qualifying and validating supplier tooling. -Responsible for validations planning/execution protocols and completion reports.

-Responsible for suppliers of Direct and Indirect materials, FG and Services for Juarez, MX and Raynham, Massachusetts sites. -Report metrics of supplier performance for Business Units of the plant. -Prepare Supplier Quality Agreements and drives discussion with the suppliers. -Quality oversight and management process to ASL (Approved Supplier List). -Provide inputs to update the audit program for suppliers based on its criticality level. -Supported regulatory body inspections for production plant, purchasing controls and suppliers. -Follow up for RMA, SCAR (Supplier Corrective Actions Request) with the suppliers.

• Design Quality team member focused on lifecycle management activities to guide the application of design change controls and risk management, while assessing the effect of changes on design input, design outputs, failure modes, test methods, and design verification and validation activities.• Evaluate and update inspection methodology, acceptance criteria, and transfer functions for products and components associated with design changes post-product launch.• Provides statistical support and analytical problem solving.• Participate in component and service supplier evaluation to maintain high quality standards.• Conduct on-site surveys for new potential suppliers.

-Review and approve protocols (MVP, IQ, OQ, PQ) for plastic mold injection, sterile packaging, heat sealers, ultrasonic welders, new process, components, etc. -Validate measurement systems test equipment through Gage R&R studies. -Lead activities to manage customer complaints analysis of returned product to determine root cause and corrective actions using appropriate root cause methodology. -Provide training to QC technicians and supervisors for all non-conformances related actions. -Evaluate risk of nonconforming material following corporate procedures based on ISO 14971 to provide effective disposition of finished goods. -Internal Auditor according to ISO 13485 / 21 CFR 820

•Provide quality engineering services to multiple customers; Endo-Sense, Boston Scientific, KCI, Stryker, ConMed and Smith and Nephew. •Transfers of new products from multiple customers. •Test Method Validation for new products transferred (DOE, IQ, OQ, PQ). •Development of quality inspection plans, quality reports. •Investigation of raw material issues with suppliers. •Responsible to implement corrective actions related to customer complaints. •Support as auditee on regulatory body inspections and audits, FDA, TUV and customers audits.

-Supervision functions for (29) QC technicians, (2) QC Team Leaders. -Investigation of Raw Material issues (Internal and External Suppliers). -Approval NCR’s dispositions for rework, control of non-conforming material. -Provided statistical analyses, solutions and assess needs for corrective actions. -DHR reviews to support customer complaint investigations. -Conduct Risk Management per internal procedures and ISO14971. -Internal auditor according to ISO 13485 / 21 CFR 820.

-Responsible for corrective actions, internal/external audit observations, including investigations. -Drive meeting to monitor target dates on the CAPA system. -Review and approve changes requested to documentation and process. -Drive compliance Quality metrics. -Participation on Kaizen projects. -Problem solving using the quality tools 5 Why’s, 8D’s. -Lead auditor for internal / external audits.