A medical device company is seeking a Quality Engineer to join its team. The ideal candidate will be responsible for applying quality engineering expertise across the Quality Management System, including certification and maintenance of compliance to ISO 13485 and 21 CFR Part 820.
Job Description
The Quality Engineer will assist with design assurance activities, including design controls, verification, and validation. They will also support development and validation of test methods and computer system assurance programs.
Required Skills and Qualifications
* Bachelor's degree in engineering, science, or related field (or equivalent)
* Minimum of 2 years' experience in a medical device or supplier environment
* Familiarity with ISO 13485, FDA QSR (21 CFR Part 820), and GMP requirements
Benefits
The successful candidate will have the opportunity to work in a dynamic and fast-paced environment, contributing directly to impactful product development. They will also enjoy working in a cross-functional team and collaborating with colleagues to uphold quality objectives and continuous improvement.
Others
The Quality Engineer will be responsible for maintaining document control through an electronic Quality Management System and performing related administrative tasks. They will also participate in risk management and usability engineering activities, as well as assist in internal and external audits and implement corrective actions as needed.