Monica Hoang
Quality Assurance Professional
North Reading
Summary
Quality Management professional with over 20 years of experience with delivering efficiency and standardization, and maintaining all ISO 13485:2016 and Quality Systems. Proficient in all QA operations, policies and procedures. Experienced in hiring and developing individual team members. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction.
Overview
20
20
years of professional experience
2
2
Certification
Work History
Quality Assurance Manager
OEM By QIAGEN
01.2017 - Current
- Develop, manage and maintain Quality Management System, including KPI identification and reporting, for a virtual company in association with QIAGEN.
- Manages QA exception system including CAPAs, SCARS, deviations, NCMRs, customer complaints and recalls. Ensures timely response, performs root cause analysis and drives continual improvement process.
- Coordinates and/or Performs Internal Audits to ensure ISO and internal QS compliance.
- Coordinates and supports audits conducted by certification bodies and/or customers. Supports and, performs external supplier audits to ensure ISO and internal QS compliance.
- Provides practical guidance to staff, individuals or teams on the interpretation of standards related to design control and risk management of life science products (e.g. ISO 9001, ISO 13485, ISO 14971, etc.).
- Participates in risk assessment and management of new products and processes.
- Manages document reviews for continued accuracy and ensures staff training is completed.
- Assist with the Implementation and maintenance of new products
- Supports or initiates investigations of CAPAs, complaints, nonconformities and deviations.
- Supervise QA staff including annual performance reviews, compensation and resource allocation to ensure deliverable timelines are met.
- Apply technical knowledge, experience and expert judgment to a broad range of difficult problems.
- Maintains a professional environment and acts in accordance with company policies, guidelines, and generally-accepted norms.
- Drive accountability and continuous improvement through training, SOPs and workflows as needed to proactively improve quality, efficiency, and standardization.
Quality Assurance Engineer
QIAGEN Beverly
01.2016 - 12.2016
- Work in collaboration with product development to ensure that the designs, procedures and outcome of the project are acceptable in quality.
- Support the creation and the maintenance of Risk Management plans including dFMEAs, pFMEAs and Control Plans according to ISO 14975 Risk Management standards.
- Write or review and approve equipment IQ/OQ and assay Verification/Validation studies in collaboration with cross-functional teams.
- Conduct and support investigations of manufacturing nonconformities, recommend, develop and implement effective corrective actions.
- Applies statistical methods for analyzing data to evaluate the current process and process changes and solve problems.
- Coordinates, collects, analyzes and distributes quality monthly and quarterly metrics.
- Participates on audits conducted by regulatory agencies and/or customers. Participates in supplier evaluation and selection assessments.
- Maintains a working knowledge of industry standards. Knows and follows the ISO 13485 quality system guidelines.
- Performs external vendor audits to ensure ISO 13485 and/or FDA compliance.
Senior Quality Control Coordinator
Microline Surgical, Inc.
02.2010 - 01.2016
- Assist manager in training coworkers, reviewing sterilization reports, and finished goods final release
- Lead Internal Auditor who manages the internal audit program including training of auditors
- MRB Coordinator in charge of scheduling monthly meetings and facilitate meeting
- Maintain calibration database.
- Corrective Action and Preventive Action (CAPA) Coordinator
- Create work instructions and revise SOP's, work instructions and forms.
- Update and present quarterly current Good Manufacturing Practices Presentation to the company.
- Maintains and ensures the training database is implemented and effective.
- Keeps track of the Sterilization Program Activities for Post-Market Routine and Projects as well as Pre-Market Projects.
- Support Post-Market Surveillance Functional Group.
Quality Control Coordinator
Microline Surgical, Inc.
11.2006 - 02.2010
- Internal Auditor
- MRB Coordinator in charge of scheduling weekly meetings and facilitate meeting
- Assist manager in training coworkers
- Assist in final packaging as needed
- Assist in revising SOP's, work instructions and forms
Quality Control Final Inspector
Microline Pentax, Inc.
03.2006 - 11.2006
- Inspection of finished goods meeting criteria for release
- Report nonconformance's related to final product to manager
Clean Room Quality Control Lead
Microline, Inc. / Microline Pentax
12.2003 - 03.2006
- In charge of inspection of in-process and finished product prior to sterilization in an ISO cleanroom
- Train coworkers
Quality Control Inspector
Microline, Inc.
12.2002 - 12.2003
- Inspect in-process and finished product in an ISO cleanroom
Education
High School Diploma -
Bachelor of Science - Mechanical Engineering Technology
12.2027
Skills
- Cause and Effect Analysis
- Continuous Improvements
- Current Good Manufacturing Practices (CGMP)
- Data Analysis
- Data Collection
- Document Control
- Employee Supervision
- Employee Training
- Knowledge of Quality Systems
- Employee Training
- Quality Assurance Guidance
- Quality Management Systems
Affiliations
American Society for Quality
Certification
- Certified Quality Auditor
- Certified Quality Process Analyst
Hobbies
- Cooking new recipes
- Computer gaming
- Digital art
- Photography
- Learning
- Listening to music
Additional Information
Will provide references upon request.
Languages
English
Native or Bilingual
Chinese (Cantonese)
Native or Bilingual
Spanish
Elementary
Timeline
Quality Assurance Manager - OEM By QIAGEN
01.2017 - Current
Quality Assurance Engineer - QIAGEN Beverly
01.2016 - 12.2016
Senior Quality Control Coordinator - Microline Surgical, Inc.
02.2010 - 01.2016
Quality Control Coordinator - Microline Surgical, Inc.
11.2006 - 02.2010
Quality Control Final Inspector - Microline Pentax, Inc.
03.2006 - 11.2006
Clean Room Quality Control Lead - Microline, Inc. / Microline Pentax
12.2003 - 03.2006
Quality Control Inspector - Microline, Inc.
12.2002 - 12.2003
Boston Latin Academy - High School Diploma,
Northeastern University - Bachelor of Science, Mechanical Engineering Technology