Manager, Quality Assurance

Position Overview

  • Reports to Director, Regulatory, Quality and Compliance
  • Full Time position
  • Competitive salary, stock option package and strong benefits

The Manager, Quality Assurance will be a key member of the QA organization.  The position will manage Quality Assurance and Quality Control activities related to product development, new product introduction, and product manufacturing, and provide leadership in fostering a culture of continuous improvement.

Key Tasks

  • Manage, improve and maintain quality methodologies, processes and procedures.  Lead continuous improvement initiatives and projects to improve processes and upgrade quality documentation electronic system to meet expanding quality activities for commercialization
  • Manage company-wide quality initiatives, and coordinate, manage and track QA team’s efforts, ensuring milestones are met within defined budgets and schedules
  • Assist with improving key company quality sub-systems such as supplier management, production and process control, risk management, CAPA, NCMR, and complaint handling and ensure that best practice software development lifecycle process is established and maintained
  • Participate in inter-department planning and management teams and work cross-functionally to establish standards and improve processes within the organization
  • Develop and trend key metrics to monitor the health of various quality sub-systems and overall quality system.  Compile and analyze data, document, summarize and report quality findings to senior/executive management and new product development teams, and recommend appropriate actions
  • Coordinate company activities for any external audits and inspections.  Maintain and ensure effective standard operating procedures are in place for Medical Device-related auditing and inspections.  Establish and conduct audit and inspection readiness training for all employees, and ensure readiness through other means such as mock audits.  Conduct 3rd party audits to ensure adherence to company requirements
  • Ensure compliance and employee adherence to internal SOPs, policies, external regulations (e.g., 21CFR Part 820 and ISO13485) and established best practices.  Ensure product development and design control activities, including verification and validation, are performed in compliance with internal procedures and standards
  • Manage Quality Assurance team.  Define priorities, delegate responsibilities and balance planning efforts with day-to-day demands.  Identify and obtain staff capabilities needed to accomplish objectives.  Responsible for ensuring that department understands and complies with quality standards and requirements, as documented
  • Oversee and handle other QA responsibilities

Job Requirements

  • Minimum Bachelors’ Degree in Mathematics, Business, Computer Science or Engineering
  • Minimum 2 years managerial experience in a quality assurance position, with proven track record of success building, leading, and managing a functional and technical QA team
  • 5+ years’ experience with FDA and ISO regulated product development and ISO quality systems, including Design Controls, Production and Process Controls, CAPA and complaints
  • Expertise or working knowledge of medical device software quality assurance across range of platforms (Mobile, Embedded, PC and Web) is preferred, including expertise of medical device software development lifecycle, software validation and software hazards analysis
  • Experience with ISO 13485 and 21CFR Part 820 – Quality System Regulations
  • ASQ Certification preferred

Skills and Abilities        

  • High attention to detail and meticulous record-keeping
  • Ability to work both independently and as part of a highly integrated team
  • Multitasking and project organization skills a must
  • Excellent communication and problem-solving skills
  • Comfortable working in a fast-paced environment
  • Must have the ability to proactively resolve issues in a diplomatic, flexible, and constructive manner

Qualified applicants are encouraged to send their resume and a cover letter including availability to 


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