Medical Device Sales

Peter Furtado

** ********* ******, ******** ** **190

Cell: 617-***-**** - ac1mom@r.postjobfree.com

Summary

Industry professional with a seasoned knowledge of medical device regulatory procedures and complaint data

analytical skills. Experience includes the medical device and biotech industries. Skills involve creating, writing

standard operating procedures, and submitting regulatory documents. Solid experience within regulatory affairs,

medical device malfunctions and adverse event FDA submissions. Strong ability to effectively convey technical

information to a general reader and to industry professionals. Resourceful administration of CAPA's and

manufacturing-related defects. Performance driven project management that creates an interested and focused

group effort. Motivates team members to garner an atmosphere of loyalty and a desire to achieve success.

Skills

Knowledge of 21 CFR Part 820, Quality System Proficient in Microsoft Excel, Word, spreadsheet,

Regulations 21 CFR Part 803, Medical Device database and presentation applications

Reporting and ISO 13485, ISO 9001 Strong analytical problem-solving skills ability to

Experience with complaint handling, support multiple projects and balance priorities

MDR/Vigilance reporting Strong communication and writing skills with high

Strong coaching, facilitation and organizational detail orientation

skills A comprehensive understanding of medical

Ongoing Process Improvement and Corrective device quality regulations, including areas of

Actions/Recalls device design, development, manufacture,

Creative problem solving directly with customers distribution, sales, service, and post-market

who request immediate attention related to surveillance

ongoing or multiple product issues

Experience

Supervisor, Post Market Surveillance

April 2014 to May 2017

Fresenius Medical Care Waltham, MA

Provided support to the overall Post Market Complaint Management process including receiving,

reviewing, and evaluating product complaints for manufactured and distributed products (equipment, drug,

and device)

Managed complaint identification, evaluation, and investigation and other complaint handling activities for compliance with applicable regulations and guidance requirements

Ensured all complaints were evaluated to determine FAR, MDR, or ADE reportability by applicable

regulations, standards, and company policy

Interfaced with all areas of the company and with all levels of management, ensuring all regulatory

obligations for compliance within the scope of the department

Provided customer support and served as a liaison between various multi-disciplinary groups including

manufacturing facilities, the medical department, clinics/customers/patients regarding product complaints,

adverse events, and potential product problems

Supervised Post Market Surveillance activities and staff to assist the Post Market Surveillance Manager in

day to day management of the department

Developed staff, managed performance, provided ongoing feedback, and was responsible for annual

assessment for direct reports utilizing the company's performance management tools

Ensured all staff daily activities were complete, accurate, and completed in a timely manner

Reduced overall complaint cycle time and decreased open complaint volume within 12 months by

implementing systematic process controls and implemented a consistent compliant file process

Ensured reviews of complaint investigations from the manufacturing plants were timely, accurate, and

consistent

Worked closely with the Post Market Surveillance Management to establish weekly Quality Performance

Metrics and Complaint Report and ensured they were generated on time and were accurate

Analyzed quality data to identify trends and reported them to management in a timely fashion

Supported the Corporate Corrective & Preventative Actions program, with particular emphasis on CAPA's

escalated from complaints

Provided supervision to Associate Post Market Surveillance Specialists, Post Market Surveillance

Specialists, Senior Post Market Surveillance Specialists, and Principal Post Market Surveillance

Specialists

Product Associate

July 2013 to April 2014

Haemonetics Braintree, MA

Created work instruction currently in use for the global complaint intake procedure

Conducted customer inquiries and documented product complaints into the database for trending and

analysis and ensured the complaint process was completed in accordance with corporate procedures

Provided audit support by accurately compiling reports and materials in a timely fashion to support internal

and third-party audits

Conducted higher-level data analysis and utilized reporting tools to verbally present data and results in a

comprehensive, detailed, and organized fashion

Worked directly with customers to resolve issues and provided quality data to respective customers as

required

Participated in and led Corrective Action and Preventative Action (CAPA) projects with cross-functional

teams

Ensured that all product complaints were screened for potential safety issues, reported accurately, and

closed out in a timely manner

Partnered with Field Service, Marketing, Manufacturing, Quality, and Sales personnel to help resolve

customer issues

Coordinated the return of product samples, performed visual inspections and preliminary investigations

related to product issues, forwarded samples and preliminary investigation reports to responsible

departments, reviewed the responses, and notified the customers of the results

Product Complaint Coordinator II

September 2011 to June 2013

Haemonetics Braintree, MA

Performed quality assurance activities associated with maintaining internal quality systems, including the

execution of the finished goods on hold process

Administered CAPA system issuing, tracking, filing, periodic updates, and input into the management

reports

Created and developed supporting documentation for Material Review Board presentations and meetings

Presented reports on data across all product lines and identified trends and drivers in detail

Provided audit support by accurately compiling reports and materials in a timely fashion

Worked directly with key customers to resolve issues, provided quality data to those customers, and

participated in key customer audits

Established and maintained the corporate complaint files subject to review by the FDA and other

regulatory agencies

Product Complaint Coordinator I

April 2009 to September 2011

Haemonetics Braintree, MA

Provided administrative expertise in receipt, processing, monitoring, and reporting of product defect

complaints, serving as primary contact

Monitored complaint activity and provided suggestions to appropriate company authorities to modify

existing manufacturing or packaging processes based upon pattern and related analyses

Documented product complaints into the database for trending and analysis and ensured the complaint

process was completed in accordance with corporate procedures

Monitored complaint activity and provided suggestions to appropriate company authorities to modify

existing manufacturing or packaging process based upon pattern and related analyses

Education and Training

Bachelor of Science: Business Administration, 2012

University of Phoenix, John Sperling School of Business Phoenix, AZ

Associate of Science: Business Administration, 1987

Quincy College Quincy, MA

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