Quality Management Engineer

KENNETH J KELLY

Worcester MA *****

*************@*******.*** 508-***-****

CAREER SUMMARY

Quality Engineer • Senior Quality Engineer • Quality Manager

Responsible Quality professional adept at providing guidance, leadership, and support for the quality of products and operations while ensuring all activities conform to applicable local and international regulations in conjunction with the company standards and requirements.

Experienced in creating and managing QMS processes and procedures for Medical, Automotive and Aerospace industries. Performance of internal and external audits to assess the effectiveness of a Quality Management System QMS. Designated Management representative.

Strong background in customer and supplier interactions.

Proficient in identifying and addressing areas of non-compliance by leading root-cause analysis and problem-solving teams.

AREAS OF EXPERTISE

Quality Systems ISO 9000 ISO 13485 AS9100 Quality Management Internal Auditing External Auditing Quality Control Quality Assurance Product Quality Supplier Quality Process Capability SPC Validation PPAP IQ OQ PQ FAI Corrective Action CAPA SCAR 8D 5Why Fishbone Problem Solving Continuous Improvement FMEA Lean Manufacturing Six Sigma Microsoft ERP MRB Communication Leadership Risk Analysis

PROFESSIONAL EXPERIENCE

Columbia Tech-Engineering Division, Westborough, MA Sept 2021–April 2024

Prototype manufacturing with intent to scale projects into full volume production.

Senior Quality Engineer

Responsible to ensure Engineering division’s adherence to Columbia Tech’s Operating Procedures and ISO 9001:2015

Collaborated with Columbia Tech and customer(s) project engineering teams to develop processes for fabrication of prototype capital equipment.

Created quality assurance protocols and inspection procedures to assure compliance with customer requirements.

MRB Coordinator

Point of contact for quality related issues, both internal and external.

Performed root cause investigations for internal, and customer reported non-conformances. Completed Corrective Actions reports.

oIssued Supplier corrective action reports for Supplier related non conformances.

oEnsured proper containment of suspect material, approval of root cause investigations in timely manner, assured implemented actions were effective in resolving the non-conformance. Collaborated with purchasing and Engineering for replacement of non-conforming material or resolution of bringing material into compliance by approving rework procedures.

Created final shipping audits to document all components presence at time of disassembly and shipment to customers final location.

Internal Quality Auditor audited processes for all Columbia Tech Divisions to ensure compliance to Corporate QMS and ISO 9001:2015 / ISO13485 standards.

Tecomet, Woburn MA April 2021-September2021

Manufacturer of metal components used for medical devices. Processes utilized, CNC machining and photochemical etching.

Quality Engineer – Contract Position

Quality Liaison for Tecomet Woburn customers. Ensured site compliance to Tecomet internal policies and procedures.

Interfaced with Program Management, and supply chain, to ensure compliance to the Tecomet quality policies.

Resolved internal / external quality issues. Generated MRB documentation ensured proper containment of suspect material.

Performed root cause investigations. Verified implemented actions effective in resolving the non-conformance issues.

IQ/OQ/PQ Validation. Generated internal validation protocols. Ensured production processes executed per validated protocols. Compiled data results, and documentation, published validation reports and submitted to customer for approval.

Maintained the Devise Master Records (DMR) and Devise History Records (DHR) in the corporate life cycle database.

Approved contract manufacturer validation protocols and final reports.

oVerified execution of protocols, ensured completeness of documentation following GDP practices.

DePuy Synthes -Spine Division Raynham, MA October 2020- March 2021

OEM of a medical device used for minimally invasive spinal operations.

Supplier Quality Engineer – Contract Position

Contracted to generate Approved supplier List for the Spine division to meet FDA requirements before filing devise for FDA Approval

Interfaced with Suppliers and J&J Microbiology group to ensure supplier compliance to Contamination Control Policy.

Collaborated with Program Management, and supply chain, to ensure compliance J&J quality policies.

Created and maintained Approved Supplier List (ASL). Performed supplier audits (remotely due to COVID)

Hologic Incorporated Marlborough, MA July2019-May 2020

A Medical Technology company focused on women’s health.

Supplier Quality Engineer

Managed the Quality relationship between Hologic and a key supplier that was producing a diagnostic medical device Under Hologic’s name.

IQ/OQ/PQ /Validation Protocols, reviewed, edited, and approved contract manufacturer protocols Verified execution of protocols, ensured completeness of documentation following GMP guidelines.

Supported improvements to existing processes and development of new processes through participation on cross functional team between Hologic and the contract manufacture. Team members included Program Directors, R&D Engineers /Manufacturing / Regulatory and compliance personnel.

Documented and approved changes through the Engineering Change Order process (ECO)

Accountable for completing CAPA’S assigned to Hologic from customers.

Issuance of Supplier corrective actions.

Ensured proper containment of suspect material, approval of root cause, and verification that implemented actions were effective in resolving non-conformance.

Reviewed and approved Device History Records (DHR) from contract manufacturer for product releases.

Maintained Device Master Records (DMR) and Device History Record (DHR) in Agile PLM system.

Sathorn Corporation, Acton MA April 2016-July 2019

A CNC contract manufacturer supplying custom components to Aerospace, Medical, and commercial markets.

Quality Manager

Primary objective was Registration of Sathorn Corporation to ISO 9001 /AS9100C.

Attained ISO 9001:2015 / AS9100C. Registration May 2018

Designated Management representative

Developed Standard operating procedures to incorporate into the QMS.

Development and maintenance of employee training matrix, Approved supplier List, FAI protocols FMEA’s and control plans as required by customers. Utilized Lean manufacturing methodologies to reduce internal waste and improve equipment and material movement and storage.

Resolved internal / external quality issues ensured proper containment of suspect material. Generated MRB reports, ensured completion of MRB activities.

Initiated root cause investigations. Approved corrective actions plans, verified implemented actions for effectiveness in resolving the non-conformance issues.

Materion Corporation Westford MA September 2015-December2015

Global supplier of precision optical components for Aerospace, Medical, and commercial markets.

Quality Engineer - Contract to perm position.

Contracted to provide Quality Engineering support for an anticipated Automotive project.

Development of Advanced Quality Plans for new product lines, Creation of FMEAs, control plans and SOPs

Generation of First Article ( FAI ) inspection packages for the defense, Aerospace and life science markets. Verified execution of approved production processes, reviewed, and approved required data compiled submission reports and submitted to customer for approval.

Initiated root cause investigations. Approved corrective actions plans, verified implemented actions for effectiveness in resolving the non-conformance issues.

Dielectrics Incorporated Chicopee, MA March 2015-May 2015

Contract manufacturer specializing in bonding thin film materials utilizing RF welding processes.

Quality Engineer - Contract to perm position.

Contracted to complete the validation process of for a medical devise.

Oversight of execution of IQ/OQ/PQ protocols. Generation of final reports and submission to customer for approval.

Modifications to FMEAs, control plans and SOPs as required.

Initiated root cause investigations. Approved corrective actions plans, verified implemented actions for effectiveness in resolving the non-conformance issues.

Injectronics Corporation Clinton, MA May 2013-December 2014

Injection Molding company specializing in molding and assembly of medical components.

Quality Engineer

Responsible for Quality Engineering activities of existing products and New Product Introduction (NPI) programs.

Oversight of execution of IQ/OQ/PQ protocols. Generation of final reports and submission to customer for approval Development of Quality plans for new product lines (NPI). Creation of FMEAs control plans

Updates to FMEAs, control plans and SOPs as required by ECO activities.

Initiated root cause investigations. Approved corrective actions plans, verified implemented actions for effectiveness in resolving the non-conformance issues.

Authored and distributed Supplier Quality Manual (SQM)

EDUCATION

Bachelor of Science Industrial Technology - 1991 University of Lowell, Lowell MA

Lean 6 Sigma Green Belt

Certificate in lean Manufacturing/ - 2009 Manchester community College, Manchester CT

Lean six sigma Black Belt - 2012 QPS institute Marlborough MA

Contact this candidate