Quality Engineers

Software Quality Engineer needed at medical products manufacturer.

 

Will develop and provide training on a software development lifecycle process. Work with cross-functional project teams to ensure required documentation meets regulatory requirements with a high degree of assurance.  Provide independent evaluation and test support to the software development process.  Work with outside software development contractors to ensure documentation meets required standards.  Conduct software validation activities and maintain documentation as required.  Maintain visibility of regulatory requirements regarding software quality.  Participate in software quality audits.  Provide status and metrics regarding product readiness as it relates to the level of software quality.  Collaborate with documentation management to ensure the appropriate software configuration management.

Requires Bachelor's degree in computer science, engineering or equivalent experience and 5+ years of direct experience in environment of software quality engineering.  Medical device experience is a plus, but not necessary.  Strong background in process development, and software quality life cycle management assurance.  ASQ or other quality related certifications a plus.  Proficient in technical writing skills and communications

 

 

Quality Engineer

 

Medical Products company needs a Quality Engineer to provide expertise in the following areas:

 

? Support the production floor.

? Manage the Material Review Board.

? Specify incoming inspection procedures and test equipment.

? Perform process validations, IQ/OQ/PQ, process improvement activities, and product qualifications.

? Provide quality input on multi-functional development teams.

? Coordinate the corrective action and complaint system

? Perform internal audits.

? Provide quality metrics data to assist in identifying areas of improvement.

 

Ideal candidate would have a B.S. in mechanical or electrical engineering and at least five years of experience as a quality engineer. Medical device industry experience preferred. Desired skills include: strong mechanical aptitude, strong verbal and written communication, basic knowledge of statistics, good knowledge of geometric tolerance, proficient computer skills, knowledge of Good Manufacturing Practice and ISO - 9001 a plus.  A two year technical certificate or Industrial or Chemical Engineering majors would qualify if well experienced in the above areas.