Quality Engineer Manager

Norton, MA - Telephone: 508-***-****, email: ********@*******.***

James J. Cipolla

Formerly ASQ Certified Biomedical Auditor-CBA

Formerly ASQ Certified Quality Manager – CQMgr.

Formerly ASQ Certified Quality Engineer – CQE

PROFESSIONAL SUMMARY

Degreed professional with 10+ years medical device quality engineering and managerial experience focused in manufacturing and R&D environments. Excellent leadership & interpersonal skills combined with expertise in team building, internal and external auditing, problem solving (RCA), facilitation, training, consulting, supplier partnering & supplier quality.

SUMMARY OF QUALIFICATIONS & ACCOMPLISHMENTS:

• ISO 13485:2016: Lead Assessor- BSI

• MDD 93/42/EEC Certified- BSI

• Design Assurance and Risk Management (ISO 14971) -BSI

• MDSAP – Medical Device Single Audit Program Certified - BSI

• GMP Requirements 21 CFR Part 820

• CFR 21, Part 803 Medical Device Adverse Event Reporting

• CFR 21, Part 806 Field Action Decisions

• FDA 483 Response Experience

• Process Validation – IQ, OQ & PQ

• GMP – Good Manufacturing Practices

• CAPA and Complaint Processing

• Directed over 12 companies to achieve ISO 9001 & ISO 13485 Certification

• Orthopedic Implant Medical Device Experience

• ISO 9001 Lead Assessor – LRQA-Lloyds Register QA

• Developed & implemented internal audit programs

• Extensive facilitation experience with cross functional groups PROFESSIONAL EXPERIENCE:

BSI Group America, Herndon, VA – (Home Based) 2019 to present Lead Assessor – Regulatory Services (Medical Devices)

• Plan, schedule manage, direct and perform ISO 13485 Medical devices – Quality Management System - Requirements for regulatory purposes

• Create ISO 13485, ISO 9001 & MDSAP Audit Reports

• Manage, review and respond to client nonconformance responses

• Manage client relations and business needs to include scope and product line extensions Cardinal Health, Mansfield, MA 2018 to 2019

Principal Risk Management Quality Engineer

Core responsibilities include remediation of Medical Device Risk Management Files to comply with EN ISO 14971:2012: Responsible to develop the following risk management documentation:

• Risk Management Plans (RMR)

• Create Hazard Identification Worksheets (HIW)

• Complaint Analysis

• Risk Assessments Charts (RAC)

• Risk Management Reports (RMR)

• Remediation DFMEA’s

• Attended Weekly Project Team Meetings

• Special Projects, training and SOP updates

Medical Leave Sept. 2017 – March 2018

Zoll Medical/Bio-Detek, Pawtucket, RI 2015 to 2017 Supplier Quality Engineer- Employee

• Perform Supplier Assessments & ensure compliance with GMP’s and Risk Management Practices (control plans, FMEA’s)

• Qualify Suppliers – Monitor Performance against established standards

• Support NPI Projects to ensure compliance with design control and risk management practices

• Initiate and Manage SCAR’s

• Perform Supplier Training

• Prepare and Present Monthly and Quarterly Metrics GE Healthcare, Westborough, MA 2014 to 2015

Lead Supplier Quality Engineer- Employee

Bio-Processors for drug and vaccine manufacture

• Perform Supplier Assessments & ensure compliance with GMP’s and Risk Management Practices (control plans, FMEA’s)

• Qualify Suppliers – Monitor Performance against established standards

• Perform Supplier Assessments

• Support NPI Projects

• Initiate and Manage SCAR’s

• Perform Supplier Training

• Prepare and Present Monthly and Quarterly Metrics Contracting Assignments: 2013 to 2014

Electrochemsolutions, Raynham, MA

CAPA & Internal Audit Manager

Lithium-Ion batteries for medical devices – Bone- saws, etc..

• Manage CAPA Process – Root Cause Analysis

• Act as Mentor and Coach for CAPA & Audit Program

• CRB Chairperson

• Maintain and Report CAPA & Audit Program Metrics

• Manage Internal Audit Program

Validant Medical Device Consulting, Fresenius, Waltham, MA CAPA Remediation Engineer- Contractor

Dialysis equipment

• Determine RCA

• Implement Solutions

• Perform VOE activities

Haemonetics, Braintree, MA

Supplier Quality Engineer - Contractor

Blood management-storage & platelet collection equipment

• Core duties and responsibilities:

o Perform supplier assessments

o CAPA/SCAR Follow-up

o Supplier Risk Assessments per ISO 14971

o Supplier Performance Assessment

Boston Scientific, Marlborough, MA 2010 to 2012

Quality Systems Manager- Employee

Surgical-catheters, medical imaging, peripheral artery intervention – balloon catheters, etc.

• Manage 6 person team consisting of 3 functions (Calibration, Supplier & Software QA) in support of Research & Development activities:

o Responsibilities include:

Resource Planning, Hiring, Budgeting, Performance Reviews, Metrics Preparation

Provide project direction, coaching and mentoring for quality engineering and regulatory compliance to technical team, consisting of a Supervisor, Sr. Supplier and Software QAE’s

Realized $17000.00 in department cost savings/avoidance via VIP-Value Improvement Initiatives

Lead implementation of process improvement and CAPA systems

Responsible for timely preparation and reporting of monthly and quarterly metrics

Review of metrics for associated trends, for possible escalation to senior management

Over-sight of Software Validation Activities associated with the Quality System and Test Equipment

Over-sight of Supplier QA activities: Onsite & Desktop Audits, supplier addition and removal from AVL

Supported the Boston Scientific Internal & External Audit Programs Aspect Medical Systems/Covidien, Norwood, MA 2009-2010 Sr. Quality Assurance Engineer – Employee

Brain sensors - Measure patient sleep stages during anesthesia – Prevent inter-operative awareness during surgery

• Provide QAE support to Sensor & Hardware Manufacturing Lines o Core duties include: MRB activities, supplier audits, operational performance metrics, process capability studies

• Create & Approve ECO’s using Agile

• Documentation of Risk Assessments

• Create & Track Nonconformance’s

• Perform Trend Analysis

• Supervise 3 person Quality Control Department

Maetrics, LLC, Indianapolis, IN 2008 2009

CQT Engineer/Consultant – Stryker Orthopedics, Mahwah, NJ Orthopaedic implants (hips, knees, spinal & pelvic reconstruction)

• Participate as member of CAPA remediation team

• Perform Stryker CAPA Gap Assessments

o Review CAPA’s for compliance with company 4D Problem Solving Process & Procedures o Identify gaps and create CAPA Gap Reports

o Schedule meetings with CAPA owners and SME’s and present findings to team o Initiate and manage CAPA remediation efforts to secure CAPA closure AUTOCAM-MEDICAL, Plymouth, MA 2007–2008

Quality Systems Manager – Contract Manufacturer Orthopedic Implants and Medical Instrumentation Orthopaedic implants (hips, knees, bone screws & surgical instruments)

• Responsible for all quality and regulatory matters

• Re-mapped all Level II processes to comply with ISO 13485 & 9001 QMS standards

• Primary interface with ISO 9001 & 13485 Registrar, customer audits and the FDA

• Responsible for internal audit program course development & delivery

• Responsible for management and execution of internal and external QMS audits

• Manager a 5 person Quality Control staff

• Manage Root Cause & Corrective Action 8D System

• Plan and manage the internal Audit program

• Developed SPC, IQA and Gage R&R training courses RAYTHEON MMC Portsmouth, RI – IDS Integrated Defense Systems 2006 2006 Sr. Performance Excellence Engineer II - Contractor

• Perform Internal Assessments, including AS9100, CMMI and Contract Compliance

• Identify opportunities for improvement

• Record assessment results in catsWeb and Internal Quality System Assessment databases ALTAIR AVIONICS, Norwood, MA - Design and Manufacture Aircraft Engine Monitors 2000-2005 Quality Assurance Manager - Employee

• Created company quality culture via extensive training efforts in a fast growing start-up

• Set-up entire QA system to include supplier management, calibration, training, tracking of nonconformance’s, corrective actions & ECO’s & manufacturing process controls

• Set up both internal and external document control systems

• Researched and implemented electronic document management system

• Coordinated company-wide training in use of this system

• Designed & implemented internal quality audit program

• Trained and mentored 10-person internal audit staff

• Developed FAA (CFR 14, Part 21) & AS9100/ISO 9001 compliant quality management system documentation

• Developed defect and cause codes to facilitate trend analysis for corrective action program

• Implemented SPC program (Gage R&R & Cpk studies & pareto analysis)

• System Reliability tracking and predictions (MTTR, MTTF, FMECA)

• Developed supplier rating and quarterly report card system

• Review complex aerospace and aviation contracts for pertinent quality requirements o Ensure quality system addresses varying OEM quality requirements o Designed and set-up company-wide training system (52-person company) o Company point of contact for all regulatory (FAA) matters ALAMO LEARNING SYSTEMS, San Ramon, CA - Management Consulting 1997-2000 Project Director-Quality Management Consulting - Employee

• Provide leadership and direction to client companies including facilitation, document development, training and management consulting services for the purpose of achieving Management System Certification to QS/ISO 9001. LLOYD’S REGISTER QUALITY ASSURANCE, Hoboken, NJ - Management System Certification Services 1993-1996 Management Systems Lead Auditor - Employee

• Planned, managed, directed and performed ISO 9000 Management System Certification Audits of client companies. Assumed Lead Auditor role for Westinghouse, Georgia Pacific, AT&T, Lucent Technology, Bell Laboratories, York International & Dresser Rand

W.R. GRACE & COMPANY, Canton, MA - Manufacture of Industrial Chemicals 1990-1993 Quality Control Supervisor/Engineer- Employee

• Supervised 3 Quality Control Technicians, prepared proposals and administered military & commercial contracts

• Performed work flow analysis and process capability studies utilizing Design of Experiment (DOE), CpK, Gage Repeatability and Reproducibility studies

HAZELTINE CORPORATION, Braintree, MA – Design/Mfr. Sonar-buoys for the US Navy 1985-1989 Quality Assurance Engineer - Employee

• Developed Military Quality Assurance/Control Programs compliant with MIL-Q-9858, MIL-STD-1520, MIL-I-45208

& MIL-C-45662

• Facilitated concurrent engineering activities leading to successful transition from FSED to FSD

• Participated in MRB & CCB activities

• Prepared Inspection Checklists

• Responsible for review and approval of ECN’s, Work Instructions and Configuration Management Plans

• Assisted with the development of supplier partnership programs

• Performed supplier evaluations

EDUCATION & PROFESSIONAL CERTIFICATIONS:

• BS Degree in Industrial Engineering/Management, Northeastern University, Boston, MA

• AS Degree in Business Administration, Northeastern University, Boston, MA

• HVAC Certificate, Northeast Institute of Industrial Technology

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