Professional Summary- Decisive Quality Manager/Auditor possessing in-depth knowledge of FDA 21 CFR 820/ISO/cGMP compliance (Medical Devices), Statistical Process Control, (IQ/OQ/PQ), APQP, PPAP, IATF, AIAG Core Tools, ISO systems, Internal and Supplier Audits, Quality Assurance and Control as well as advanced understanding of Quality, Personnel, Vendor management and New Product Development. Professional with acute operational understanding and presentation skills

Professional Experience

QUALITY ASSURANCE MANAGER Feb 2021-PRESENT

GRAVER TECHNOLOGIES LLC NEWARK, DE

•Directly responsible for managing quality systems for Halal, Kosher, NSF, ISO, and customer specific quality requirements.

•Lead, plan and execute 5S events across facility.

•Maintain and update Food HACCP program.

•Led Value Stream Mapping (VSM) event for a $7M+ for a 8% productivity gain.

•Improvement of product lines to realize a savings of 149 Hours/annum

•Co-ordinate internal, external, halal, kosher, etc. audits.

•Maintain, publish and report monthly KPI’s to all business leaders. Engages with employees to develop and sustain quality culture.

•Equipment qualification, Factory acceptance testing (FAT), site acceptance testing (SAT) and validation execution.

QUALITY MANAGER JAN 2018- Feb 2021

FERRO CORPORATION (Electronics Packaging Material Manufacturer) King of Prussia, PA

•Directly responsible for maintenance and upgrade of quality system based on ISO 9001:2015 QMS and IATF 16949 (implementation and management of core tools- SPC, MSA, APQP, FMEA, control plan, 8D)., including Corrective preventive actions, internal audits, document control, supplier quality, incoming inspection, in-process inspection, and final product release.

•Developed, and wrote validation structure (IQ/OQ/PQ) for 200+ equipment and 40+ test methods.

•Developed policies, procedures, guidelines, and templates in support of validation activities. Supported the team and proactively ensured that Validation Master Plans, qualification and validation protocols and reports are aligned with internal guidelines.

•Act as a change agent to challenge status quo to implement new processes and databases by involving all key stakeholders.

•Lean Initiative reduced manual data entry through policy change (manual to electronic) reducing storage space enhancing data access capabilities.

•Lean Initiative- reduced motion and wait time of incoming inspection process by 17%

•Implemented processes to comply with ISO 9001:2015 QMS, got facility certified to ISO 9001 2015 revision

•Started with a team 2 and hired 6 to build quality department to align with department goals, wrote job descriptions and conducted hiring of key personnel.

•Implemented IATF 16949:2016, from inception to implementation, collaborating with all key managers, directors, and stakeholders.

•Provided leadership and technical support for all validation activities.

•Managed project timelines of validation and ensured all validated parameters are conforming.

•Orchestrated operations policies and procedural changes by involving other department managers.

•Implemented changes in QMS affected by usage of software like SAP, Minitab, JMP, NWA and SharePoint.

•Utilized DMAIC (Six Sigma) approach to complex test methods to reduce variation resulting in ~20% variation reduction.

QUALITY CONTROL MANAGER MARCH 2011 – JAN 2018

ROBIN INDUSTRIES, INC. (Plastic and Rubber Molding- injection and Transfer) Berlin, OH

•Directly responsible for maintenance of quality system based on FDA 21 CFR 820 (cGMP), ISO 9001, TS 16949/IATF 16949, ISO 13485 and ISO 14001 standards and compliance for Class I and II medical Devices (e.g. knee surgery kit device).

•Hosted FDA audit, Registration, Compliance, Internal audits, and Customer Audits (typically 8-10 audits/ year)

•Conduct Supplier, and internal audits for quality control and ensure supplier and internal operations are aligned to company goals.

•Performed Value Stream Mapping, and DOE (Design of Experiments) for new and existing processes to understand/rectify bottlenecks and to understand process characteristic interactions.

•Directed a team of 14 employees (Quality Engineer, Lab Supervisor, group leaders, document controller and QC technicians).

•Prepared Validation Master Plan (VMP) for validating analytical laboratory equipment.

•Hands on experience in formulating Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) for validating

•Executed IQ/OQ protocols to validate manufacturing facilities following the latest GMP regulations.

•Involved in conducting GAP analysis and setting up remediation plan.

•Authored, signed off and reviewed/wrote Master Validation Plans, IQ/OQ/PQ protocols

•Wrote 21 CFR 820, ISO 13485 and IATF 16949 QMS from inception to implementation.

Developed Site level CAPA system in compliance with FDA 21 CFR 820 QSR’s (cGMP) for Class I and Class II medical devices, including DMR, DHR management. Managed, Administered CAPA's (Corrective and Preventive Actions) -Lead and guide to assure corrective actions are resolved in timely manner, root cause analysis is completed, and corrective actions are documented, implemented, and verified.

•Conducted FAT and SAT for critical packaging equipment.

•Oversaw MSA (Measurement System Analysis), process capabilities (CpK) and GRR (Gage Repeatability & Reproducibility) studies to validate new products. Lead and supported APQP, and Quality Core Tools (PPAP, FMEA, MSA, SPC, 8D, 5Y, A3)

•Designed, developed, and managed Quality Control Plans, inspection plans, SOP’s and systems specific to customers.

•Solely responsible for the overall performance, and compliance for the Site Quality Management functions consisting of Receiving Inspection, Material Testing & Document Control, In-Process and Final Inspection and Product Release.

•Orchestrated changes in QMS, by changing policies, procedures and mentoring personnel affected by change.

•Reviewed and approved customer quality requirements during contract review, completed PPAP, APQP processes, Statistical Process Control (Minitab), and documented Control Plans, pFMEA and Process Flow Diagrams to maintain compliance with TS 16949/IATF 16949 standards.

•Represent Quality Control department and departmental functions to upper management.

•Responsible for working within allocated budgetary targets.

Sanofi- Pasteur Inc (PHARMACEUTICALS)

Manufacturing & Process Co-op June 2008 - December 2008

•Assisted in conducting process and equipment validation - installation Qualification (IQ) Specification, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification.

•Assisted validated analytical laboratory equipment such as HPLC, Autoclaves, Sterilizers and Incubators in compliance with FDA regulations.

•Assisted in generating Validation Summary Report to summarize and document all validation activities

•Assisted in Involved in all aspects of the computer systems validation lifecycle, to comply with FDA regulations (21 CFR Part 11)

CONTINUOUS IMPROVEMENT PROJECTS:

Eliminated redundant compound testing needs, resulting in approximately $7000 in savings.

Consolidated packaging supplier base, resulting in approximately $ 4500/annum in savings and eliminating additional administrative cost.

Streamlined standard packs to reduce overall packaging material consumption, resulting in $6500 in annual savings.

PROJECT MANAGEMENT

Implementation of 21 CFR 820 guidelines – (9 months)

Implementation of ISO 9001:2016 Standard – (6 months)

Implementation of IATF 16949 Standard - (11 months).

Product testing and equipment qualification - (14 months)

ADDITIONAL EXPERIENCE:

Quality Engineer Co-op Nuvasive Inc. June 2010 - December 2010

Lab Assistant Rochester Institute of Technology August 2007 - May 2010

Quality Management Co-op RPC Photonics January 2009 - March 2009

Quality/Process Engineer EMS INDIA Inc July 2003 - September 2005

EDUCATION

West Chester University - Master of Business Administration (M.B.A.), 2019 – 2020 (Expected)

Rochester Institute of Technology- GPA 3.4 - M.S., Manufacturing and Mechanical Engineering Technology, 2007 - 2010

North Maharashtra University, GPA 3.01 -BS, Mechanical Engineering, 1997 - 2003

CERTIFICATIONS

Certified Quality Engineer (ASQ)

Certified Six Sigma Green Belt (ASQ)

Certified Lead Auditor- IATF 16949:2016

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