Summary
Overview
Work History
Education
Skills
Timeline
Generic

Pao Her

Kansas City

Summary


Quality management professional with 20 plus years of proven track record for process improvements and ensuring compliance with ISO 9001 and 13485 quality standards. Proven ability to collaborate effectively with cross-functional teams and achieve significant results. Known for reliability and adaptability in dynamic environments, with strong skills in process optimization, quality assurance, and compliance.

Overview

28
28
years of professional experience

Work History

Quality Manager

InfuSystem
03.2023 - Current
  • Successful management of 13 Quality team members across 7 Depots (Rochester Hills, MI, Canton, MA, Lenexa, KS, Bakersfield, CA, Santa Fe Springs, CA, Dallas, TX and Mississauga, Ont)
  • Successful in maintaining ISO 9001:2015 and 13485:2016 accreditations across 6 Depots and 200 employees which includes annual surveillance and regular recertification audits
  • Successful in maintaining FDA regulatory compliance for medical device servicing, complaint handling and recall for all Depots
  • Successful in maintaining MDEL compliance and audits with Health Canada and FDA compliance and effectiveness check compliance as part of FDA Recalls
  • Responsible for maintaining, updating, and training to all QMS procedures and protocol to ensure good alignment with OEM Medical Device Service requirements and regulatory compliance with the Quality Management System (QOP, Work Instructions, Forms, Device Master Record, Risk Management, CAPA, NCR, Change Control, Design Transfer, Validation and Complaint)
  • Successful in organizing and leading internal and external ISO Audits, Quality Reviews, Management Reviews, and Risk Management Reviews
  • Successful in organizing and leading the NCR, CAPA and SCAR program to effectively close out findings, implement appropriate changes, and monitoring and measuring of effectiveness
  • Successful in managing and meeting weekly, monthly and yearly quality metrics for 30 different Medical Devices and associated disposable for all depots
  • Responsible for service calibration, testing and compliance that meets Medical Device requirements
  • Successful in vendor and supplier audits to maintain and create new business relationships for Medical Device Sales and Servicing
  • Successful in working with major OEM Medical Suppliers (ICU, FK, BBraun, Cardinal Health, BD, Baxter, and Eitan) regarding Quality Service agreements, recalls, technical issues, and joint collaborations
  • Successfully worked directly with all Sales Team regarding product compliance and customer satisfaction to ensure continuous business growth
  • Technical manager in charge of all technical review, guidance, and recommendation for new product implementation

Quality Assurance Director

Plastikon Healthcare
11.2021 - 12.2022
  • Successfully oversaw and managed 20 Quality team members (laboratory, office and production floor) for 3 shifts, 7 days a week
  • Successful in maintaining ISO 900:2015 and 13485:2016 accreditations and implementation of USP testing requirements to ensure Medical Device and Pharmaceutical regulatory compliance
  • Successful in maintaining FDA regulatory compliance for 21 CFR part 11, 210, 211, 803, 820 and ICH Q7, Q8, and Q9
  • Responsible for maintaining, updating, and training to all QMS procedures and protocol to ensure good alignment with product testing, traceability and regulatory compliance with the Quality Management System (Batch Record, Device Master Record, CAPA, OOS, NCR, Change Control, Design Transfer, Validation and Complaint)
  • Successful in organizing and leading internal and external Quality Audits and Management reviews
  • Successful in organizing and leading remediation project related to open 483 findings including creating timelines, deliverables, and direct communication with FDA and external consultants
  • Successful in organizing and leading the OOS, NCR and CAPA program to effectively close out findings, implement appropriate changes, and monitoring and measuring of effectiveness
  • Successful in managing and meeting quality metrics (less than 1% quality defects allowed) for 15 different product lines (Pharmaceutical Solution, Food Beverage, Medical Device, Medical Component) with an average daily output of 1.2 million parts per day manufactured in a ISO 7 and 8 environment on 3 shifts, 7 days a week
  • Successful in identifying, resolving, and implementation of AQL Quality checks in manufacturing and laboratory to increase productivity and minimize downtime and loss of revenue
  • Successful in managing and ensuring water quality compliancy for dedicated WFI and PW system
  • Successful in managing aseptic and sterilization (terminal and filtration) formulation and manufacturing process
  • Responsible for Plant and laboratory calibration, testing and compliance that meets Pharmaceutical and Medical Device requirements
  • Directly in charge of vendor site audits and qualification for all manufacturers of critical raw components (API, Excipient, Resin, packaging)finished product
  • Technical manager in charge of all technical guidance and recommendation for global technical service, critical vendors, S&M, and senior management
  • In charge of technological and product innovation and process improvement for CMO Product line

Quality Assurance Manager

Trinity Biotech
06.2013 - 11.2021
  • Successful validation and implementation of clean room infrastructure for aseptic and ISO level 7 and 8 manufacturing and scaling of Covid VTM (Viral Transport Media) for 3 full shifts of 100 employees
  • Successful in creating and maintaining ISO 9001:2015, 13485:2016 and MDSAP (Health Canada) accreditations which includes annual surveillance and recertification audits
  • Responsible for maintaining, updating, and training to all quality procedures and protocol to ensure good alignment with product testing, traceability and regulatory compliance with the Quality Management System (CAPA, NCR, OOS, Change Control, Design Transfer, Validation and Complaint)
  • Successful in maintaining FDA regulatory compliance for 21 CFR part 11, 210, 211, 803, 820 and ICH Q7, Q8, and Q9
  • Successful in organizing and leading internal and external Quality Audits and Management reviews
  • Successful in organizing and leading remediation project related to open 483 findings including creating timelines, deliverables, and direct communication with FDA and external consultants
  • Successful in organizing and leading the OOS, NCR and CAPA program to effectively close out findings, implement appropriate changes, and monitoring and measuring of effectiveness
  • Directly in charge of vendor site audits and qualification for all manufacturers of critical raw components (API, Excipient, Resin, packaging) finished product
  • Technical manager in charge of all technical guidance and recommendation for global technical service, critical vendors, S&M, and senior management
  • In charge of technological and product innovation and process improvement for Hemoglobin Product line
  • In charge of creating and submitting Hemoglobin Variant Assay 510K testing and validation plan and protocol for IRB approval
  • Successful identification and coordination of 8 clinical studies at 4 designated clinical sites
  • Point person for identifying and liaising with the site coordinators, communicating and training of test requirements, and technical guidance for site all issues including concerns and issues related to data interpretation, protocol guidance and proper equipment use
  • Successful in completion of all data review, interpretation and summarization of 10,000 patient test results in full compliance with FDA, CLSI and 510K protocol submission requirements

Quality Control Manager

Trinity Biotech
03.2004 - 05.2013
  • Quality Control manager of all consumable and non-consumable products manufactured for 9 different HPLC platforms and 60 associated finished good products in accordance to GMP, Aseptic Manufacturing and GLP protocols
  • Responsible for and successfully managed and trained a team of 15 QC chemists and 40 HPLC test instruments to consistently achieve a 30% yearly growth
  • Responsible for successful transfer, implementation, and scale up of gel synthesis production for our stationary phase product to ensure consistent sustainment of product to our third-party manufacturers and producers
  • Successful in maintaining FDA regulatory compliance for 21 CFR part 11, 210, 211, 803, 820 and ICH Q7, Q8, and Q9
  • Successful in sourcing raw products, contractual negotiation and compliant validation and implementation of new products in order to sustain and improve the boronated affinity and ion exchange product lines
  • High aptitude for interpreting and troubleshooting issues using chromatography, statistical data interpretation, and working knowledge of chemistry and instrumental functionality

Quality Control Chemist

Pfizer Animal Health
05.2002 - 04.2003
  • Testing of raw API and Excipient and finished material according to USP requirements that went into the production of 24 pharmaceutical animal products in accordance to FDA regulatory guidelines using cGMP and GLP standards
  • Stability testing of Finished Good products to ensure potency and performance compliance
  • Maintenance of 3 GC and GC/MS instrument and reagent stock used for in-process and finished good testing
  • Responsible for GC/MS, titration, pH testing of raw chemicals, in-process and finished good products in the required time to ensure consistent production and shipment of product

GC/MS VOC and SVOC Manager

Pace Analytical
08.1997 - 04.2002
  • In charge of 10 different GC and GC/MS assays for NELAP accredited environmental testing and reporting of volatile and semi-volatile organics in drinking water, groundwater and wastewater monitoring and management in accordance to EPA and NPDES regulatory guidelines and standards
  • Responsible for maintaining, updating, and training to all quality procedures and protocol to ensure good alignment with product testing, traceability and compliance with the Quality Assurance Program (CAPA, NCMR, Change Control, Validation and Complaint)
  • Responsible for and successfully managed a team of 8 chemists, 20 GCs and 4 GC/MSs test instrument’s to achieve quarterly and yearly goals for testing and result turnaround time
  • Maintained and ran 10 GC/MS and volatile analyzers to ensure a high level of product output
  • Successful organization and implementation of wellness program for the company

Education

Bachelor of Arts - Chemistry

Bethany College
Lindsborg, KS
05.1996

High School Diploma -

Turner High School
Kansas City, KS
05.1992

Skills

  • Quality Assurance
  • FDA Regulatory Compliance
  • Health Canada Regulatory Compliance
  • Laboratory Management
  • Medical Device Mfg Management
  • Medical Device Service Management
  • Quality Management System
  • MDSAP
  • ISO 9001:2015
  • ISO 13485:2016
  • Quality Internal/External Audit
  • CAPA/NCR/SCAR
  • FDA Recall/Remediation
  • Risk Management
  • Design Transfer/Validation
  • Microsoft Word/Excel/PowerPoint
  • Microsoft Outlook
  • Continuous improvement
  • Supplier relationship management
  • Customer satisfaction
  • Analytical mindset
  • Operational excellence

Timeline

Quality Manager

InfuSystem
03.2023 - Current

Quality Assurance Director

Plastikon Healthcare
11.2021 - 12.2022

Quality Assurance Manager

Trinity Biotech
06.2013 - 11.2021

Quality Control Manager

Trinity Biotech
03.2004 - 05.2013

Quality Control Chemist

Pfizer Animal Health
05.2002 - 04.2003

GC/MS VOC and SVOC Manager

Pace Analytical
08.1997 - 04.2002

High School Diploma -

Turner High School

Bachelor of Arts - Chemistry

Bethany College

Similar Profiles

CREATE PROFILE
Pao Her