Quality Assurance Engineer

Under the general direction of the Vice President of Quality Assurance & Regulatory Affairs, is responsible for quality planning and implementation relating to design development and production. Provides leadership in problem resolution (corrective and preventive action) concerning product and processes.


Specific Responsibilities:

1.Develop and implements processes to produce product that meets appropriate regulatory standards, e.g. 21 CFR 820 and ISO 13485:2003

2.Develop and validates methods and instructions for in-process and final product testing.

3.Generates and maintains systems to monitor quality data; such as manufacturing yields, failure trending, quality costs, price of non-conformance, and other metrics regarding operations performance.

4.Apply risk management techniques to situations concerning product or process quality.

5.Conduct product failure investigations within defined procedures.

6.Works with manufacturing engineering to develop and validate production processes that assure the manufacture of EP MedSystems products is consistent.

7.Working with manufacturing and engineering, creates the DMR for designs transferred into manufacturing.

8.Act as a liaison with contract manufacturers to ensure EP MedSystems specifications are understood and manufacturing activities conform to the quality system standard and regulation identified by EP MedSystems
REQUIREMENTS
Bachelor’s degree in engineering or related technical field (or equivalent combination of education and experience). BSEE on a quality assurance team and in a medical device environment would be a plus.

Minimum 5 years’ related experience.

Specific knowledge of regulatory requirements.