Quality Engineer Supplier
Resume:
Robert Zagwyn
** *********** **., ******, **. ***49
********@*****.***
As a seasoned Supplier Quality Engineer, I have had extensive quality management systems exposure and experience with external and internal manufacturing across multiple fields and commodities. (Printed circuit board assembly, electro-mechanical assembly, and injection molding processes across multiple quality management systems (ISO 9001, 13485, AS9100, FDA CFR 820, DoD). I am currently looking for employment opportunities and open to new roles at any level.
EXPERIENCE:
Insulet
July 2023 – Feb 2024
Sr Supplier Quality Engineer
> Create supplier quality agreements, as required.
> Conduct and maintain supplier audits and schedule.
> Review/approve supplier process validation protocols and reports.
> Review/approve engineering change order requests.
> Implement/coordinate Quarterly Quality/Business Reviews with critical suppliers.
> Build and maintain cross-functional relationships to communicate and resolve manufacturing/quality/compliance issues.
> Create/review deviation requests for validity and corrective action
> Support new supplier qualification/assessments
> Manage and process supplier corrective action requests (scars) to closure
Quanterix
Feb 2023 – July 2023
Sr Supplier Quality Engineer
> Tasked with cleaning up the Approved Supplier List – Reduce the number of suppliers
> Improve supplier selection/evaluation processes
Cynosure - Westford, Ma
June 2021 – January 2023
Sr Quality Engineer
> Develop and circulate supplier scorecard (present monthly to executive team and share with appropriate suppliers).
> Create supplier quality agreements, as required.
> Improve MRB turn-time and reduce current MRB inventory ($500K reduced to $68k within three months, through weekly meetings)
> Conduct and maintain supplier audits and schedule.
> Monitor manufacturing of cosmetic creams and ointments through batch records and filling operations.
> Improve supplier corrective action request (SCARs) supplier response (RC/CA) and turn-times.
> Implement supplier process performance / monitoring KPI metrics (Test and Inspection Yields).
> Create/review supplier process validation plans and reports.
> Process engineering change requests.
> Create and maintain transparent supplier relationships (establish a trusted partnership).
> Implement / coordinate Quarterly Quality/Business Reviews with critical suppliers.
> Qualify suppliers, maintain supplier files, and approved vendor list from a quality perspective.
> Process FAIs as part of supplier and part qualifications
> Support or lead CAPA root cause and preventive action tasks
> Support external compliance audits (MDSAP- Medical Device Single Audit Program, ISO Certification audits, MDR- European Medical Device Regulation)
> Build and maintain cross-functional relationships to communicate and resolve manufacturing/quality/compliance issues.
ZOLL Medical - Chelmsford, Ma
Apr 2019 – June 2021
Sr Supplier Quality Engineer
> Supplier development and support
> Internal manufacturing support
> Create supplier process validation plans (IQ/OQ/PQ) and reports for injection molding equipment/ tooling
> Process supplier change requests (SCR) through our Agile product data management tool via engineering change requests (ECR) and engineering change orders (ECO)
> Review deviation requests for validity and corrective action
> Support new supplier qualification/assessments
> Conduct/support periodic supplier assessment, quality, and process audits
> Manage MRB for injection molded components
> Manage and process supplier corrective action requests (scars) to closure
> Assist and drive in CAPA investigations
> Address and resolve all supplier-related discrepancies.
> Develop quality plans for incoming inspection and supplier final inspection.
> Support cross-functional teams to deliver the highest degree of quality and reliability to our internal and external customers.
Novotech Inc (via TRN staffing agency) - Acton, Ma
Nov 2018 – Feb 2019
Quality Engineer-Temp Contract
> Responsible for creating the QMS documents, forms, and identifying KPIs for ISO 9001:2015
certification. Stage 1 audit was successful (only 2 recommendations noted).
> Implementation of QMS, KPI data analysis and drive Corrective Action processes
Helen of Troy Health & Home - Marlborough, Ma
April 2009 –October 2018
Supplier Quality Assurance Manager
> Responsible for managing and developing supplier quality assurance processes of global
contract manufacturers. Primary focus is the implementation of supplier quality systems,
monitoring supplier performance, corrective and preventive action, supplier's adherence to the
Supplier agreements, perform and assist in internal/external audits of quality systems,
manufacturing/test processes, fire-health & safety, and code of conduct for adherence of
contractual and regulatory requirements, ISO13485:2016, ISO9001:2015, SA8000, and FDA.
> Review verification & validation protocols and reports (IQ/OQ/PQ) to assure robust product
quality and ensure best in class processes, design guidelines, and practices are utilized.
> Act as a ‘bridge’ to transfer product design to manufacturing through manufacturing readiness
reviews, process audits, and lessons learned.
> Lead periodic quality review meetings with external/internal stakeholders, drive Root Cause
Analysis (RCA), implement robust corrective/preventive actions, and ensure proven
effectiveness.
> Identify, analyze and interpret quality data for trends, risks, opportunities, and make
appropriate recommendations to drive improvements.
> Respond to customer field issues with CAPAs that are effective in preventing recurrence.
> Coordinate root cause/ corrective action for global regulatory complaints through the following
agencies: Bfarm, MHRA, TFDA, FDA.
> Single point of contact for all quality related issues between Helen of Troy, customers, and
suppliers.
Crane-Azonix Corp - Billerica, Ma
October 2007 – April 2009
Supplier Quality Engineer
Military/Marine/Oil & Gas Grade Displays and Military Grade Computers
> Develop and drive supplier quality, internal quality, and customer quality initiatives.
Responsibilities include, analyze supplier process/quality, customer return and internal quality
data for possible defect trends and process issues. Performing root cause analysis,
implement/close corrective/preventive actions internally and at the suppliers.
> Supplier development through process/quality audits, assures suppliers have proper process
controls and inspection checks in place.
> Responsibilities include First piece qualification process, initiation and review of ECOs, MRB
coordinator, Supplier Scorecards, ISO and AS9100 compliance, collect and analyze customer
repairs data, supplier performance, and internal data for continuous improvement, internal
process audits, calibration maintenance, and create/maintain a Supplier Manual.
> Identify and create process and inspection documentation for manufacturing cells.
General Electric - Billerica, Ma
May 2003 – July 2007
(Sensors for food, oil & gas, and water)
Supplier Quality Engineer
> Drive supplier quality, internal quality and customer quality initiatives. Responsibilities include
driving and performing root cause analysis, implement corrective/preventive action for supplier,
internal and customer quality and process issues. Weekly meetings with suppliers and internal
manufacturing managers to review and address manufacturing and quality issues based on
collected yield, defect, repair and warranty return data.
> Team with mechanical and electrical manufacturing engineers to drive continuous process
improvements at the supplier and internal operations.
> Perform quality/process audits at suppliers and internal operations.
> First piece qualification review and validate CTQs and PPAP (Production Part Approval Process)
which includes PFMEA, process maps, gauge r & r, quality/process control plans.
> Review ECOs as required; represent quality/process engineering at ECO review board meetings.
> Supplier/Internal/Customer corrective action coordinator. Lead efforts of Investigation and
closure of all corrective action requests.
> Non-conforming material/MRB coordinator.
> Support sourcing efforts in transferring products to be manufactured and tested in LCRs (low
cost regions)
Lucent Technologies - Westford, Ma
January 2000 – April 2003
Supply Quality Engineer
> Perform supplier quality, internal quality and customer quality initiatives. Responsibilities
include weekly meetings with suppliers and internal manufacturing managers to review and
address manufacturing and quality issues based on collected yield, defect, and repair &
warranty return data.
> Perform quality/process audits at suppliers & internal operations.
> Support Life Cycle Management and the Buyer/Planners with product rationalization projects.
Ramp up new products to the suppliers and ramp down end of life products.
> Drive root cause, and implement corrective/preventive action for supplier, internal and
customer quality and process issues.
Raytheon - Tewksbury, Ma
October 1980 – Dec 1999
Quality Engineer
> Quality data analysis
> Readiness Reviews
> ECO review
> MRB chair
> Manufacturing/Test process monitoring
EDUCATION:
> Attended Fitchburg State College – Business Management and Engineering courses
> Attended UMass-Lowell – Engineering courses
> Attended Fisher College– Business Management
> Attended Nichols College– Business Management
No degree obtained (Due to the travel demands of my role as a supplier QA engineer, I was
never able to complete a degree program)
Skilled in: Agile, Arena, Oracle, QAD, Microsoft tools, PCB / PCBA / Wire harness, IPC Standards, Lean
Manufacturing .
QSG (Quality Support Group) Training by James F Leonard
Certificates in:
> Failure Modes and Effects Analysis (FMEA / PFMEA)
> Statistical Process Control (SPC) Tools & Concepts
> CAPA TOOLS for Effective Problem-Solving
QPS (Quality & Productivity Solutions)
Certificate in:
> Lean six sigma
Contact this candidate