JESSE A. SCOTT

848-***-**** adyp0s@r.postjobfree.com LinkedIn New York, NY

Certified Quality Engineer

Over 11 years of experience in the Medical Device and Pharmaceutical industries with in-depth knowledge of FDA compliance ensuring current good manufacturing practices (cGMP). Proven experience managing Corrective and Preventive Action (CAPA) and Post Market Surveillance (PMS) projects. Knowledge of regulatory/standard requirements (e.g. ISO 13485, 21 CFR 820, EN ISO 14971). Expertise in the development of product risk management files (risk management plan, DFMEA, and risk management report).

AREAS OF EXPERTISE

Skill Area

Data Analysis

Computer Systems Validation

ANOVA

Conformity Assessments

Corrective and Preventive Action

Statistical Process Control

Instrumentation

Technical Writing

Laboratory

Quality Assurance

Process Control

Maintenance

CERTIFICATIONS

Certified Quality Engineer

American Society for Quality-2019

Microsoft Access Advanced Certification

Microsoft Excel Advanced Certification

EDUCATION

Bachelor of Science, Chemical Engineering

University of New Haven

West Haven, CT

Associate of Science, Biotechnology

Middlesex College

Middletown, CT

TECHNICAL SKILLS

JMP

LIMS

Minitab

SAP

MS Office

Agile

TrackWise

AutoCAD

PROFESSIONAL EXPERIENCE

Compliance Engineer, Consultant Oct 2022 – Present

Ferring Pharmaceuticals, Parsippany, NJ

Performed Root Cause Analysis involving cross-functional teams using 6M methodology

Wrote Deviation Investigation reports summarizing findings

Coordinated Corrective And Preventive Action (CAPAs)

Utilized Quality Management Software (TrackWise) for Change Control

Prepared and updated Standard Operating Procedures (SOPs) including Decommissioning Equipment

QA/QC Engineer Feb 2020 – Oct 2022

Fujifilm Electronic Materials, North Kingstown, RI

Developed and implemented statistical control plans for key analytical equipment

Performed Gauge Repeatability and Reproducibility (GR&R) studies for all equipment used to test certificate of analysis (CofA) parameters

Created business continuity plans (BCPs) to qualify equipment using accuracy, linearity, precision, correlation, and matching.

Conducted Oneway ANOVA testing to determine statistical significance of process changes

Wrote quality control procedures and created visual workflows to document processes

Quality Engineer, Consultant Jan 2019 – Feb 2020

Becton Dickinson, Warwick, RI

Collaborated with stakeholders to develop and implement project strategies and goals focusing on results in areas of improving quality and cost containment and revenue enhancement.

Interpreted engineering drawings and created inspection methods and aesthetic specifications.

Reviewed and approved engineering change control to comply with procedures and project objectives.

Supported operational qualification (OQ) and performance qualification (PQ) with data analysis.

Analyzed and prepared data for Post Market Surveillance reports.

Product Technical Requirement Specialist, Cons. Jan 2018 - Nov 2018

Johnson & Johnson, DePuy Synthes, Raynham, MA

Conducted gap analysis on product technical requirement files and reported findings to support remediation project.

Compared PTR documents to ensure compliance with global standards as well as manufacturer’s specifications.

Defined plan to approach gaps per license by evidence work stream and aligned approach and approval between work streams.

Executed plan to complete justification, rationale, or testing.

Completed analysis of data and finalized PTR documentation for submission

Quality Engineer, Consultant May 2017 – Oct 2017

Cadence, Cranston, RI

Created quality assurance test record templates based on ISO specifications.

Tested and issued non-conformance reports for product which did not meet specifications and compiled rejection rate trends and pareto charts.

Issued CAPAs and performed root cause investigation.

Performed Gauge R&R and process capability studies.

Quality Engineer, Consultant Jun 2015 – Feb 2017

Zoll Medical, Pawtucket, RI

Generated deficiency reports with solutions for corrective measures. Authored summaries of conformance for compliant devices.

Reviewed design history records of assigned projects and researched and compiled post market surveillance reports.

Conducted gap analysis reporting and proposed improvement recommendations.

Initiated and performed conformance assessments of medical devices against 60601-1 standard.

Reviewed and updated technical files for assigned projects. Wrote gap assessments and memos to tech file.

Product Specification & Special Project Engineer Feb 2013 – Jun 2015

Harrison Specialty, Canton, MA

Led implementation of supplier corrective actions with adherence to organizational requirements.

Created and presented monthly metrics using Statistical process control (SPC) and performed root cause analysis on non-conformances.

Provided assistance to the QA team to achieve a passing mark on the ISO 22716 GMP audit in Sept 2013.

Managed the incoming packaging quality process and established the sampling, and testing protocols.

Quality Engineer Sep 2011 – Feb 2013

Philips-Home Healthcare Solutions, Framingham, MA

Oversaw the complaint systems for all of the home medical devices.

Prepared quality metrics including initial and ongoing product quality using Pareto charts and failure rates.

Led the Corrective and Preventive Actions (CAPAs) review process.

Guided the QA team to successfully pass the June 2012 FDA audit.

Assembled key process indicators for a quality management review and based on this initiative, changes were identified which triggered Corrective Action.

QA Specialist, Consultant Jan 2011 – Sep 2011

Covidien, Norwood, MA

Coordinated the equipment system for the medical device manufacturer.

Audited engineering change order approvals.

Inspected materials using various tools including caliper and micrometer.

Project-managed the packaging and testing of equipment process being transported to offsite locations.

Scheduled maintenance and calibration of equipment.

Additional Experience:

CAD Draftsman & Special Projects Engineer (12/2007 – 12/2009), Unilever, Clinton, CT

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