Lead Quality Assurance Specialist
5 days ago
The company, a leading medical device manufacturer, specializes in innovative heart failure management solutions. Founded in 2013, they are dedicated to improving outcomes for individuals suffering from chronic heart conditions through advanced remote monitoring technologies.
Job Description
As a Senior Quality Engineer, you will drive the day-to-day implementation of the Quality Management System (QMS) with a focus on continuous improvement. You will support manufacturing, supply chain, and design assurance activities, representing the quality function cross-functionally. Your key responsibilities will include:
- Leading QMS continuous improvement activities
- Ensuring delivery of overall quality strategy and supporting achievement of business quality objectives
- Collaborating with the wider team to ensure necessary QA activities are planned, executed, and documented
- Interpreting relevant standards and ensuring the company meets requirements
- Developing and reviewing test specifications, part specifications, and design specifications with cross-functional teams
Required Skills and Qualifications
You should have a Bachelor's Degree in Engineering, Science, or a related field, with at least 3 years of experience in a medical device quality/design assurance role. Recent regulatory experience, including FDA regulations, ISO 13485, Medical Device Directive, and other applicable national and international regulations and standards, is essential. A Master's degree in Engineering, Science, or a related field is desirable. Experience in implantable medical devices and process development and change management in a regulated environment are also highly valued.
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