Quality Manager

Location: California  |  Kentucky  |  United States
Sector: Life Sciences
Consultant: Chris Hutchinson
Job Reference: HQCHQED
Salary: £63300 - £87900
Job Status: Permanent / Full Time

Quality Engineer – Design

Define User Needs by translating the voice of customer feedback to design user needs.

Define Functional Specifications by understanding how to take a user need to a quantifiable specification.

Conduct Risk Assessments by working with current product quality data, FDA MAUDE database, and other sources to find issues with currently marketed products, assess clinical risk to customer and patients, and offer design recommendations to improve product safety, reliability, or performance.

Benchmark Designs by Gathering and analysing data to benchmark and compare the performance of multiple products using specifications or empirical test data.

Develop, research, and identify methods for inspection of raw materials, components, and finished products at suppliers and within internal manufacturing facilities.

Provide Usability / Human Factors Engineering to Identify areas for improving intuitive use, usability of products through usability protocols, formative studies – executing studies with actual users (surgeon, nurse, technician, and specialists).

Design prototypes and debug solutions of simple complexity.

Work with mechanical and software engineers to ensure that all modules will integrate properly.

Present designs for peer review to improve the quality of a design and share best practices.

REQUIRED COMPETENCIES

Endoscopy experience

4 to 10 years + years of related experience

Hands on design experience  

Bachelor’s degree in Engineering or Science

Previous Medical Device experience is preferred

Previous Quality engineering

Risk Management

Design Controls experience

Looking to pay from $90,000 up to $125,000 depending experience, plus bonus  

If you are interested in this please get in touch and send your CV, we are looking to interview candidates as soon as possible.