Summary
Overview
Work History
Education
Skills
Certification
Affiliations
Timeline
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MBITHI MUTHINI

Hayward,CA

Summary

Accomplished Quality and Regulatory Affairs leader with over 20 years of experience in the medical device industry, specializing in ISO 13485, FDA QSR, CE Marking, and global regulatory submissions. Skilled in leading cross-functional teams, implementing quality systems from the ground up, and managing all aspects of compliance, complaint handling, CAPA, and audits. Adept at navigating complex regulatory environments to drive business goals.

Overview

24
24
years of professional experience
1
1
Certification

Work History

Vice President of QA/RA

Expanding Innovations, Inc.
Mountain View, CA
08.2018 - Current
  • Company Overview: Privately held company focused on a unique expandable interbody fusion device technology.
  • Part of a team of five that was charged with developing this technology and bringing it to market.
  • Led the implementation of the quality program ensuring all compliance and manufacturing processes were defined, documented and implemented fully.
  • Coordinated the regulatory approvals of the devices in compliance to state and national distribution requirements.
  • Privately held company focused on a unique expandable interbody fusion device technology.
  • Supplier control: Implemented a comprehensive Supplier qualification program for outsourced manufacturing.
  • Regulatory submissions: Developed and implemented regulatory strategies for spinal implants and coordinated successful FDA 510(k) submissions.
  • Third-party audits: Hosted State, federal and customer auditors, resulting in successful audits.
  • Supervision: Managed QA/RA staff and department objectives.

Director of Quality Engineering

Providence Medical Technology, Inc.
Pleasanton, CA
07.2017 - 08.2018
  • Company Overview: Privately held company that designs, develops, and markets cervical spinal solutions using a posterior approach.
  • Led the company’s quality engineering program, charged with validations, biocompatibility assessments, cleanliness, and sterilization of product, and as an integral member of the design and operations teams.
  • Privately held company that designs, develops, and markets cervical spinal solutions using a posterior approach.
  • Team player: Represented Quality in design and operations teams.
  • QA operations: Oversaw lot release and validation testing (LAL, bioburden, shelf life).
  • Risk management: Contributed to risk management and quality improvement initiatives.
  • Biocompatibility: Streamlining of the biocompatibility assessment of new products.

Director of QA/RA

Spine View, Inc.
Fremont, CA
01.2010 - 01.2017
  • Company Overview: Privately held company that developed percutaneous tools designed used for spinal surgeries.
  • Hired to take over the quality and regulatory function in the company to meet the need of company to expand into global markets.
  • Oversaw the regulatory applications and approval of the devices in China, Japan, South Korea, MEA, LATAM, etc, and authored numerous technical files for CE Marked products marketed in the EU.
  • Privately held company that developed percutaneous tools designed used for spinal surgeries.
  • FDA and EU submissions: Led submissions of five 510(k)s and four CE Marks.
  • Global submissions: Directed global regulatory strategy for 12+ international markets.
  • Quality systems: Oversaw internal and external audits.

VP of Quality

Vertos Medical, Inc.
San Jose, CA
01.2008 - 01.2010
  • Company Overview: Privately held company (acquired by Stryker) that was started to develop minimally invasive treatments for LSS (lumbar spinal stenosis).
  • Recruited as the third team member to lead the quality function and obtain CE Mark for the start-up company.
  • Oversaw the sterilization and packaging validations while implementing the quality system to meet ISO 13485 standards and FDA 21 CFR Part 820 requirements.
  • Privately held company (acquired by Stryker) that was started to develop minimally invasive treatments for LSS (lumbar spinal stenosis).
  • Regulatory agency resolution: Mitigated warning letter resolution to an amicable settlement with the FDA.
  • Quality system management: Served as Management Representative for regulatory audits.
  • Department management: Managed departmental budgets and QA/RA teams.

Director of QA

Evera Medical, Inc.
Foster City, CA
01.2007 - 01.2008
  • Company Overview: Privately held company medical device company focused on developing & commercializing novel biomaterials for tissue reconstruction, repair and augmentation.
  • Responsible for implementing the quality system and obtaining CE Mark.
  • Returned the manufacture of the device from a contract manufacturer to in-house by establishing a CER in order to improve quality.
  • Submitted complaint reports and resolved corrective actions.
  • Privately held company medical device company focused on developing & commercializing novel biomaterials for tissue reconstruction, repair and augmentation.
  • CE Mark: Led QA efforts and achieved CE mark within 5 months.
  • Audits: Hosted audits and assured adequate corrective action.
  • Clean room: Set up CER to allow in-house assembly of the product.

QA Manager

St. Francis Medical Technologies, Inc.
Alameda, CA
01.2005 - 01.2007
  • Company Overview: Was a start up company marketing an interspinous process decompression implant that was acquired by Kyphon for $725 million.
  • Obtained ISO 13485 approval and a CE Mark for the company using existing validation data in six months.
  • Oversaw the establishment of a robust complaint handling system using FileMaker Pro software.
  • Was a start up company marketing an interspinous process decompression implant that was acquired by Kyphon for $725 million.
  • CE Mark: Led quality systems implementation and obtained CE Mark for a Class III device in six months.
  • Complaint handling: Managed complaint handling and reporting.
  • Doc to stock: Set up dock to stock acceptance process of finished goods in a virtual manufacturing setup.

Operations QA Manager

Kyphon, Inc.
Sunnyvale, CA
01.2003 - 01.2005
  • Company Overview: A publicly traded company that developed the kyphoplasty procedure.
  • Quality engineer with responsibilities in the launch of several new products before transitioning to operations QA management.
  • Trouble shot CER issues and streamlined the sterilization and LAL lot release process to save money, samples and time for product release.
  • A publicly traded company that developed the kyphoplasty procedure.
  • Cost reduction: Utilized family grouping strategy for sterilization and used periodic monitoring of LAL, saving the company over 600K annually in testing and opportunity costs.
  • Management: Oversaw IQA, MRB, and regulatory compliance in manufacturing.

Senior Quality Manager

Novare Surgical Systems
Cupertino
01.2001 - 01.2003
  • Company Overview: Privately held company focused on cardiovascular devices for use in beating heart coronary artery bypass grafting (CABG) procedures.
  • Implemented an ISO 13485 certified quality program and obtained CE Mark for several devices.
  • Privately held company focused on cardiovascular devices for use in beating heart coronary artery bypass grafting (CABG) procedures.
  • Recalls: Managed Class II and III recalls with >95% completion.
  • Management: Build and Managed QA/QC staff.
  • Audits: Hosted successful FDA and CE audits.

Education

M.S. - Biology

Jackson State University

Skills

  • Regulatory Submissions
  • Quality Systems Management
  • Risk & Compliance
  • Technical Expertise
  • Leadership

Certification

  • Lead Auditor, ISO 13485 – RAB Certified
  • Certified Quality Auditor – Biomedical (CQA-Biomedical)

Affiliations

  • Board Member - Kusoma International, a non profit organization

Timeline

Vice President of QA/RA

Expanding Innovations, Inc.
08.2018 - Current

Director of Quality Engineering

Providence Medical Technology, Inc.
07.2017 - 08.2018

Director of QA/RA

Spine View, Inc.
01.2010 - 01.2017

VP of Quality

Vertos Medical, Inc.
01.2008 - 01.2010

Director of QA

Evera Medical, Inc.
01.2007 - 01.2008

QA Manager

St. Francis Medical Technologies, Inc.
01.2005 - 01.2007

Operations QA Manager

Kyphon, Inc.
01.2003 - 01.2005

Senior Quality Manager

Novare Surgical Systems
01.2001 - 01.2003

M.S. - Biology

Jackson State University