Quality Engineer Medical Device

Our consulting firm is experiencing rapid growth and we are looking for additional quality engineers to support our medical device clients. We help innovative medical device companies around the world design, document, manufacture, and sell their medical device products.

We pride ourselves on providing the best, most efficient, and effective medical device consulting in the world. This is a great opportunity for the right candidate to join a fast-growing company helping to support innovative medical technology.

Responsibilities

Work as a quality consultant for medical device companies and various types of devices, diagnostics, and SaMD.

Provide Quality Engineering support of for the design, risk analysis, and verification / validation of new medical device products.

Work closely with startup medical device companies and products to ensure all aspects of the design history file, technical file, and risk management file are completed during the development process.

Assist product development teams during development of new devices and software. Responsible for implementation of product quality plans, verification / validation protocols and reports.

Maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements. Keep current on all applicable best practices and statutory regulations governing the design, procurement, manufacture, marketing, and distribution of medical devices.

Conduct and support internal and external audits for clients to maintain compliance with the FDA, ISO 13485, CE Mark (MDR), MDSAP.

Support post-market activities including CAPA, non-conformances, complaint handling and investigation, supplier assessment, adverse event reporting, and other activities.

Candidates are able to work remotely from home with optional travel as needed.

Qualifications

• Bachelor's degree or equivalent in Engineering or related field
• 1-5+ years' of industry experience
• Strong knowledge of quality tools used in the industry
• Analytical and quantitative approach to problem solving
• Strong communications skills

Benefits :