What do medical device quality jobs involve?

Quality professionals working in medical devices ensure that the manufacturing process meets the external standards set by regulatory bodies such as the FDA, alongside the internal standards set by the company. These standards are applied throughout the medical device development lifecycle. The medical device industry is constantly evolving and innovating, using the latest technology to advance the diagnosis and treatment of injury and disease. This makes the role of medical device quality jobs more important than ever.

In some companies, particularly smaller ones where resources are limited, quality professionals will also be responsible for regulatory affairs and compliance.

What responsibilities do medical device quality jobs have?

Having a career in quality in medical devices comes with some very specific responsibilities which are crucial to the development of new products and their delivery to market. Key duties include:

• Producing quality documentation
• Representing quality assurance and quality management within the business
• Creating lean QA processes
• Quality assurance testing
• Implement and maintain the compliance of the QMS according to ISO 13485:2016
• Managing CAPAs, non-conformances, complaints and other quality related activities
• Lead on quality reviews and audits
• Leading and training quality staff
• Managing quality budgets
• Ensuring compliance with specific standards like IEC 62304 (software), iec 60601 (electrical safety) amongst others 
• Working directly with R&D, regulatory affairs and marketing on new product development
• Supporting the design verification and validation activities
• Lead FDA inspections and support the company’s PMA process from a quality perspective
• Supervising and coordinating internal and external stakeholders in regards to complaint handling
• Cooperating with risk management and post market surveillance team
• Development and optimisation of procedures for lifecycle management

Types of medical device quality jobs

Medical device quality professionals can choose to work with the following types of medical devices:

• General medical devices
• Active implantable medical devices
• In vitro diagnostic  medical devices
• Software as a medical device (SaMD)
  
  

There are lots of quality jobs within these medical device types, including:

• Quality Assurance Specialist
• Quality Assurance Manager
• Quality Assurance Team Leader
• Director of Quality 
• Head of Quality 
• Quality Engineer
• Vice President RAQA
• Validation and Verification Engineer
• Head of Quality Engineering
• Vice President Quality
• Document Control Manager
• Software QA Specialist
• Vigilance Specialist
• Quality Systems Manager
• Senior Design Assurance Engineer
• Site Quality Director
• QMS Specialist
• Quality Manager

Medical device companies near me

Are you looking for a new medical device quality job? Check out our latest vacancies below or head to the Vacancies page to search for your preferred location.

What is the average medical device quality salary?

It’s very difficult to say what the average medical device salary is because of how much it can vary between location, company size and seniority. You can download our Salary Report to drill down into these variables and see how your salary compares to other medical device quality professionals around the world.

How do I become a medical device quality specialist?

Medical device quality qualifications

There are many routes into medical device quality careers and there aren’t a specific set of qualifications that are required. Once you embark as a quality professional, you can gain training and qualifications as your career progresses. One popular course for people working in medical device quality is lead auditor training according to ISO 13485.

Medical device skills and experience

The medical device skills and experience you need to secure your dream medical devices job will depend entirely on the type of role you’re applying for, the type of medical devices you want to work with and have in the past, and your professional seniority.

These are common medical device quality skills and experience requirements we see from the medical device companies we work with:

• Experience with creating and maintaining quality systems and processes
• Developing quality assurance teams
• Being the face of quality within a business and working with stakeholders to ensure cross-functional collaboration