Job Description

MUST HAVES: Ensure adherence to the Risk Management Process including development of Risk Management Plan. Develop Quality Plans for new products. Work with Supplier Quality on Control plans, First Articles, PFMEAs, and process validations for new parts. Perform on-site auditing of suppliers, as appropriate. Review and approves all production release specifications and drawings. Ensure Critical to Quality characteristics, SPC dimensions, and inspection characteristics  Coordinate with Quality Assurance and Manufacturing Engineering Degree in Mechanical Engineering, Electrical Engineering, Bio Medical Engineering (BME), or related field 

GOOD TO HAVE Experience in regulated design environments, such as medical device development, FDA, or ISO registered work experience Experience with Risk Management ISO 149713. Experience with Quality Engineering, Product Development, or Design Verification engineering Project Management Skills Ability to communicate effectively, both verbally and in writing, to technical and non-technical audiences. Provide technical assistance to Manufacturing, Quality and Operations groups throughout the early production builds and launch. Support the effort through documentation and training as required.

KEY RESPONSIBILITIES Responsible for ensuring the quality and reliability of new products through the appropriateness of design inputs, adequacy of verification and validation testing, and identification of key quality characteristics for the device

KEYWORD Quality Assurance; Design Quality; Quality Engineer; Medical Device Quality  

Regards

N. Jagdish Reddy

Qualifications null Additional Information

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