Marla Tim
Billerica,MA
Summary
Expert Quality Systems Engineer ready to take ownership of installing and maintaining Quality manual systems. Provides cost-effective resources to maintain efficiency and performance levels. Dedicated to applying novel management approaches to reduce support costs and minimize service calls. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
5
5
years of professional experience
Work History
Quality Assurance and Systems Specialist
Schleifring NA
10.2022 - Current
- Provide QA review of SOPs, Deviations/Nonconformances and CAPAs, change controls and process document changes through the electronic document management system
- Ensuring manufacturing compliance with applicable procedures and batch records, providing real-time review of manufacturing record documentation, and working with operations to resolve manufacturing issues
- Daily lab operations and execution of testing to support manufacturing operations/validation/or development studies
- Review manufacturing shop floor documentation
- Develops and revises procedures and work instructions
- Evaluate all sources of incoming customer information, identify, investigate and document Customer Complaints, perform trend analysis and maintain all records
- Builds relationships internally within and with cross-functional teams
- Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies
- Routinely recognizes and resolves Quality issues; Informs management of proposed solutions
- Translates product requirements into inspection criteria and process capability
- Supports QMS internal audits and supplier/customer site audits
- Improves and monitors inspection processes
- Supports, upholds and enforces compliance to ISO 9001 regulations
- Investigates and documents customer returns and complaints
- Implements measurable effective corrective & preventive actions
- Perform Internal Audits and External Supplier Audits
- Managed several interdepartmental projects
- Performs CAPA Investigations and A3/8D forms for solutions on process deviations.
Quality and Regulatory Systems Specialist
Hyperice, Inc.
06.2021 - 10.2022
- Coordinate record keeping and documentation supporting compliance activities, including required licenses and audit schedule
- Perform Internal Audits and External Supplier Audits
- Assist in implementing and managing electronic document management system
- Oversee personnel training and competency program
- Manage Equipment and Facilities maintenance records
- Provide QA review of SOPs, Deviations/Nonconformances and CAPAs, change controls and process document changes through the electronic document management system
- Support vendor audit program as needed
- Escalate issues to QA management and support QA Management with various projects as needed
- Assist in development, maintenance and improvement of a quality system that is in compliance with ISO 13485, MDSAP, and MDR
- Provide support for the creation, implementation, and maintenance of policies and procedures
- Ensures the integrity and oversees that the operation of the calibration system complies with the quality system
- Provide support for documentation requirements such as releases, change orders, etc
- Ensures the document control system for the location complies with the quality system
- Ensure appropriateness of all corrective and/or preventive actions and assist when required in the root cause analysis and identification and implementation of resolutions
- Conduct and assist with internal audits, as required, to assess the effectiveness of quality system, identify weaknesses, recommend corrective actions, and review effectiveness
- Train employees per appropriate FDA GMP, ISO, Medicare and other relevant procedures
- Develops training modules as needed
- Collaborate with Customer Service, Product Service, Product Development and Sales teams to facilitate required actions
- Determine the Medical Device Reportability of all identified Customer Complaints, take appropriate action and maintain all records
- Keep current with regulations, accreditations, certifications, and registrations pertaining to the current product line
- Familiarity of Quality Assurance concepts, processes, and systems and the demonstrated ability to implement them
- Demonstrated working knowledge of ISO13485 and 21CFR820.
Quality System Specialist
FUJIFILM Medical Systems USA, Inc.
08.2019 - 05.2021
- Evaluate all sources of incoming customer information, identify, investigate and document Customer Complaints, perform trend analysis and maintain all records
- Determine the Medical Device Reportability of all identified Customer Complaints, take appropriate action and maintain all records
- Coordinate all Mandatory Field Notifications and Engineering Change Orders, take appropriate action and maintain all records
- Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action
- Perform Corrective and Preventive Action and Nonconforming Product activities
- Perform Internal Audits and External Supplier Audits
- Coordinate U.S
- FDA remediation activities
- Prepare Management Review Meeting presentations
- Comply with all applicable U.S
- Food and Drug Administration (U.S
- FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards
- Attend all department and company-wide team meetings as needed.
Education
Bachelor of Science - Environmental Sciences
University of Massachusetts Boston
Boston, MA05.2025
Skills
- Types 85 wpm,
- fluent in Khmer
- Microsoft Office (Word, Excel, PowerPoint, Outlook),
- Expert with Salesforce, Oracle, Onbase, Echo, Filebound, MP3, EProvider, ETQ, ExFM, SAP
- Expert understanding of ISO 9001:2015 and ISO 13485:2016
- Process Data Analysis
- Cross-Functional Collaboration
- Documentation Management
- Operational Standard Development
- Training and mentoring
Timeline
Quality Assurance and Systems Specialist
Schleifring NA
10.2022 - Current
Quality and Regulatory Systems Specialist
Hyperice, Inc.
06.2021 - 10.2022
Quality System Specialist
FUJIFILM Medical Systems USA, Inc.
08.2019 - 05.2021
Bachelor of Science - Environmental Sciences
University of Massachusetts Boston