Tamara Perceval Email & Phone Number

Boston, Ma, Us

Marlborough, Ma, Us

Marlborough, Ma, Us

Marlborough, Ma, Us

* Supports the Boston Scientific Quality System as a team member of the NCEP Team and through quality disciplines, decisions and practices. * Applies effective, systematic problem-solving methodologies in identifying, prioritizing communicating and resolving quality issues. * Communicates non-conformances to applicable personnel.* Ensures completion of nonconforming reports and updates to the eCAPA system as needed. * Interfaces with Site/Plant representatives and Internal/External functional groups regarding nonconforming issues.* Performs investigation of nonconforming material through review of processing records and SAP/WMS. Execute the disposition of material through approved nonconforming reports or coordinate the return of material to the Manufacturing plants. * Provides support for Site Audits, including preparation, front room scribing and backroom support.* Supports departmental, functional, divisional and corporate quality goals and priorities.* Build quality into all aspects of work by maintaining compliance to all quality requirements.* Identify, prioritize and resolve quality related issues.* Supports and executes site implementation readiness review for Global/Corp SOPs/WIs..* Seeks out cross-functional subject matter experts and secures required technical and product information. * Coordinates review/edit/approval process per department procedures. Ensures accuracy, readability and consistency. * Supports continuous improvement activities at a personal, departmental and cross-functional level.

Marlborough, Ma, Us

Responsible for supervising daily operations of Returns, Complaints, Kitting and Quality Control.* Overseen daily functions and work flow to meet operational objectives, assured safety and achieved effective core metrics performance.* Identified and resolved operational issues and managed addressing non-conformance matters.* Supported Global and local Rework projects by organizing bins and locations for new product families.* Updated department procedures and SOPs to ensure they were accurate and in compliance to enable employees to perform their duties. * Used both Lean and 5S principles to help productivity within the workplace.* Served as internal liaison for team operators, including preparing reports and presentations on functions and performance.* Increased visibility to the Returns department by working with multiple sites in trying to identify opportunities to increase the restock percentages.*Developed the Biohazard room to Compliance with collaboration across multiple sites.

Paris, France, Fr

Provides compliance support for quality operations. Complete analysis, identify issues and provide recommendations for compliance improvements. Perform review of results to audit process or equipment compliance to FDA and GMP requirements. Help remediate processes and systems in accordance with company standards and regulatory requirements. Demonstrate understanding of 21 CFR Part 11, 210, 211 and equivalent global regulations.Interact with project teams and applicable research groups as they impact the quality operation.Interact with senior internal and external personnel on significant matters often requiring coordination between organizations.Provide guidance to End User on their SOPs.

Marlborough, Ma, Us

Oversee Returns, Complaints and Manufacturing/Kitting Inspections. Assign and prioritize work flow for assigned daily activities of Inspectors. Communicate with multifunctional groups on RGA statuses and troubleshoot through issues. Identifying and implementing process improvements, leading of projects, providing input to performance reviews, enforcement and support of company policies and procedures.• Gather and present Monthly Metrics to Management and Senior Executives.• Leads and coordinates department activities to support new product lines, control pre-release locations and control short shelf life products and tracks the departments daily metrics.• Create CR’s to help improve departmental changes and lean out processes. • Manage Non-Conforming Reports. Process Investigation, Risk, Containment, Disposition and Closure.• Establish and implement departmental policies, goals, objectives and procedures.• Encouraging, identifying, and developing best practice strategy.Ensuring compliance to all Environmental Health & Safety goals & objectives.

Marlborough, Ma, Us

Oversee Incoming Inspection receipt, assign and prioritize work flow for assigned daily activities of Quality Control Inspectors. Communicate with multifunctional groups on load status and quality related activities. • Leads and coordinates department activities to support new product lines, control pre-release locations and control short shelf life products.• Incoming Inspection Point Person for all product launches• Prioritize inspection activities by analyzing daily reporting to assess team and individual performance to meet / exceed release requirements. • Streamlined the DHR folder creation process by reduced unnecessary movements by 135’ per each sterile Run record, test form and amended PSRR printed• Reduced waiting time in the DHR folder creation process by arranging the inspection personnel tasks to produce a better process flow• Front Room Scribe for multiple sites supporting TUV, FDA, DEKRA and Corporate Audits resulting in zero findings across multiple sites.

Marlborough, Ma, Us

Performed product release activities for products being processed through the Quality Control Department, which included performing inspection functions to written procedures and specifications. Reviewed Sterilization processed documentations and proactively assisted the Group Lead balance workloads.• Responsible for performing Lead Operator duties in QA department for BSC Manufactured products and OEM vendor product lines• Selected to perform challenge testing and IQ/PQ protocol execution in support of new system applications.• Verified Certified Sterility Documents and Release Test Forms• Completed Final Review and Release of Finished medical devices.

Marlborough, Ma, Us

Worked cross-functionally to provide support on an as needed basis for Quality Inspection and other departments. Performed other duties, such as assistance with general questions and problems. Completed forms with the results of inspections accurately and conforming to GDP requirements. • Performed inspection activities on medical products such as Sterility inspection and Incoming inspection. • Responsible for identifying and initiating non-conformances, segregating materials and reporting results