Summary
Overview
Work History
Education
Skills
Timeline
Generic

Mala Taylor-Jones

Bartlett,TN

Summary

Quality Analyst with expertise in identifying and resolving critical quality issues through effective research methodologies. Demonstrated ability to work independently while utilizing strong analytical and organizational skills. Proven track record of enhancing quality processes and ensuring compliance with industry standards.

Overview

19
19
years of professional experience

Work History

Analyst II, Complaint Handling

Olympus Surgical Technologies America, OSTA
04.2023 - Current
  • Perform timely post-market activities for global complaints that require evaluation, assessment, and/or follow-up for regulatory reporting determinations, and regulatory submissions.
  • The complaints are related to reported adverse events, including serious injury, infection, or death.
  • Evaluate complaints and communicate with field specialists, sales representatives, engineers, technicians, clinicians, and customers directly, as well as utilize different data sources to understand the facts and details surrounding the complaints.
  • Draft and send Customer Response Letters when requested and/or warranted.
  • Complete routine, as well as complex assignments, with occasional direction from the manager.
  • Adherence to Medical Device Quality Systems regulations, including ISO 13485, 21 CFR 820, and 21 CFR 803.
  • Comply with all relevant medical device regulations and standards, including, but not limited to, FDA regulations, ISO standards, and internal company policies.

Analyst I, Global MDR Submission Analyst

Olympus Surgical Technologies America, OSTA
08.2020 - 04.2023
  • Reviewed incoming complaints to determine the facts of the case.
  • Performed due diligence follow-ups with the reporter, contact, or the customer to obtain additional fact-based information.
  • Reviewed and evaluated any additional information attached to the file or available in ancillary source systems.
  • Determine if additional information is required to make a preliminary MDR file.

Senior R&D Coordinator

Olympus Surgical Technologies America, OSTA
Bartlett, TN
07.2012 - 08.2020
  • Provided administrative support to Research & Development (R&D) personnel, focusing on designated projects to ensure deadlines were met.
  • Managed the R&D and Marketing Library, and outsourced clinical articles via available sources when requested.
  • Organized and coordinated vendor credentialing for staff to ensure credentialing standards were met for various sites visited. Also managed an annual on-site vaccination clinic for annual vaccinations.
  • Served as a liaison for Document Control to ensure that Engineering Change Orders and Change Orders were created, completed, and implemented.
  • Coordinated and arranged logistics for in-house and off-site meetings, including meeting space, supplies, and catering requirements.
  • Trained employees on the Oracle Project Management Timesheet as a designated super user.

Marketing Coordinator

Olympus Surgical Technologies America, OSTA
Bartlett, TN
04.2010 - 07.2012
  • Optimized administrative support for marketing team to enhance project focus for managers.
  • Collaborated with legal team to manage HCP Consulting Agreements and ensure compliance.
  • Tracked consulting services and payments per Olympus' HCP policies and procedures.
  • Coordinated logistics, equipment, supplies, and requests for both in-house and off-site meetings.

Sales and Marketing Administrator

Olympus Surgical Technologies America, OSTA
Bartlett, TN
04.2008 - 04.2010
  • Delivered comprehensive administrative support to Sales and Marketing teams.
  • Analyzed sales data monthly for reports to regional sales managers and V.P.
  • Managed distribution of sales and marketing materials to representatives and healthcare providers in a timely manner.

R&D and Marketing Administrator

Olympus Surgical Technologies America, OSTA
Bartlett, TN
04.2007 - 03.2008
  • Delivered comprehensive administrative support to Sales and Marketing teams, boosting project efficiency.
  • Cross-referenced competitors' products to refine sales strategies and enhance competitiveness.
  • Shipped sales literature to customers and sales representatives promptly.
  • Assembled, tracked, and shipped demonstration scope kits to sales representatives, and monitored their return.
  • Collaborated monthly with Cost Accountant for accurate financial reconciliation.

Customer Service Specialist

Olympus Surgical Technologies America, OSTA
Bartlett, TN
06.2006 - 03.2007
  • Managed accounts and provided exceptional customer service to ensure client satisfaction.
  • Upsold products when possible.
  • Trained new hires on departmental processes, policies, and procedures.

Education

Bachelor of Science - Fashion Merchandising

University of Memphis
Memphis, TN

Skills

  • Complaint evaluation
  • Quality assurance
  • Data analysis
  • Regulatory compliance
  • Risk assessment
  • Client services

Timeline

Analyst II, Complaint Handling

Olympus Surgical Technologies America, OSTA
04.2023 - Current

Analyst I, Global MDR Submission Analyst

Olympus Surgical Technologies America, OSTA
08.2020 - 04.2023

Senior R&D Coordinator

Olympus Surgical Technologies America, OSTA
07.2012 - 08.2020

Marketing Coordinator

Olympus Surgical Technologies America, OSTA
04.2010 - 07.2012

Sales and Marketing Administrator

Olympus Surgical Technologies America, OSTA
04.2008 - 04.2010

R&D and Marketing Administrator

Olympus Surgical Technologies America, OSTA
04.2007 - 03.2008

Customer Service Specialist

Olympus Surgical Technologies America, OSTA
06.2006 - 03.2007

Bachelor of Science - Fashion Merchandising

University of Memphis

Similar Profiles

CREATE PROFILE