Jeff Knoblett

678-***-****

Quality Engineering Professional for Medical Devices

SUMMARY:

** *****’ experience in providing quality and validation solutions within the medical device industry

Solid knowledge of quality tools such as SPC, capability studies, Gage R&R, Normality test, design of experiment, FMEA, Control Plans, PPAP & GD&T

Experience in process validation principles – has written and executed validation deliverables including IQ, TMV, OQ, PQ, DOE, FMEA, and summary reports

Skilled in conducting risk assessments

PROFESSIONAL EXPERIENCE:

Supplier Quality Engineer

Pfizer (Treximo Life Sciences) Jan 2020 – present

Remediation effort for supplier monitoring for Pfizer sites that make combination products.

Develop guidance documents and SOP for Vendor Scorecards and SCAR process

Evaluating suppliers for Pfizer combination product sites that have components that are being reclassified to medical devices and working with those affected suppliers to ensure that they have the proper controls and quality system elements required to support medical device components

Revising Quality Agreements for suppliers with updated supply channel categories.

Supplier Quality Engineer

Orchid Orthopedic (American Contract Group – Bridgeport, MI Oct 2019 – present

Remediation effort for CAPAs and NCMRs

Functions as Supplier Quality Engineer for the Bridgeport facility

Supports quarterly supplier monitoring activities, including analyzing scorecard information and issuing SCARs for suppliers below the acceptable threshold.

Communicates nonconformance issues with suppliers, follows up on root cause and corrective action efforts.

Supplier Quality Engineer

Philips Healthcare (USDM Life Sciences) – Bothell, WA Aug 2018-Oct 2019

Works on cross-functional CAPA team to resolve issues related to suppliers

Provides annual quality reviews for assigned suppliers

Performed assigned tasks related to CAPAs

Provided support to onboard and evaluate new supplier

Performed capability analysis on CTQs for purchased parts

Assigned to APQP CAPA to review and remediate critical suppliers.

Review Control Plans, PFMEAs for critical suppliers.

Assisted suppliers with designing and executing MSA on new and existing equipment.

Responsible for assisting in creating all applicable process documentation.

Supplier Quality Engineer

Ethicon, Inc (Oxford Life Sciences) – Albuquerque, NM Jan 2018-Aug 2018

Supports the supplier nonconformance process for the Albuquerque facility.

Initiates NCMRs in ETQ, initiates containment activities, and assists operations with initial investigation.

Communicates nonconformance issues to suppliers, issues nonconformance reports to suppliers, reviews root cause and corrective actions, effectivity plans, closes NCMRs in ETQ.

Support validation efforts for packaging area.

Assisted with process nonconformance’s, including calibration

Senior Quality Engineer

Gerresheimer – Peachtree City, GA Mar 2017-Dec 2017

Provide statistical analysis for production parts/assemblies

Supports new product development and handoff of new products to production

Supports environmental monitoring including particulate and bioburden testing

Wrote procedures for assembly and packaging operations.

Wrote and executed validation protocols (IQ, OQ, PQ)

Wrote and executed test method validations (Gage R&R, Attribute Agreement)

Training inspectors, SQC technicians, and supervisors on the following: new procedures, new equipment, new measurement methods, new inspection criteria, Component/product defects and failure modes

Quality Engineer

Lake Region Medical – Trenton, GA 2014-2017

Provide quality assurance support for Specialty Value Stream.

Wrote and updated procedure and Process Control Documents.

Participate in validation activities, including writing and executing IP/OQ/PQ.

Wrote and executed test method validations (Gage R&R, Attribute Agreement)

Worked in conjunction with NPD team to validate new products and handoff to

Operations.

Initiate corrective action activities for customer complaints.

Reviewed quality data for trends to identify opportunities for improvement and corrective actions.

Collaborate with Engineering and Operations on CI Projects

Participate in internal audits to confirm compliance to procedures, ISO 13485 requirements

Assists in compiling quality data, including gage R&R studies, process capability studies, trending of product defects, trending of functionality data for finished product, dimensions on components or finished product, raw material inspection/sampling, incoming component inspection.

Assists in identifying root causes and coordinate corrective action to quality issues in Production, Packaging and Inspection

Various Assignments (full time) 1993 –2014

Quality Engineer/Supplier Quality Engineer/Quality Manager roles in the medical device industry, automotive industry, and consumer electronics.

EDUCATION

M.S. in Quality Assurance -2006

Southern Polytechnic State University, Marietta, GA

B.B.A. in Management - 1988

West Georgia College, Carrollton, GA

A.A. in Business Administration - 1987

Dalton College, Dalton, GA

SKILLS

Practical experience and formal training in process improvement tools, including SPC, DOE, and Six Sigma methods.

Practical experience and formal training conducting quality system audits.

Experience using statistical software packages, including SQCPack and Datamyte, MS Excel, Minitab,and MS Access,

Completed ISO 9001:2000 Lead Auditor course – BSI

Completed Design Control and Software Validation courses – AAMI

Experience in writing SOP’s, work instructions for quality systems.

Completed Root Cause Training – ASQ/Lake Region Medical 2015

CQE Certification – ASQ – December 2016

CQA Certification – ASQ – June 2019

Completed SSGB Certification – NCR 2013

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