Description
One of Houston's top medical device providers is currently seeking for a Quality Assurance Engineer.The quality assurance engineer role entails providing quality engineering support to Manufacturing Operations by resolving quality related issues, improving product quality, investigating customer complaints and reducing costs.
Main Responsibilities
- Investigate/analyze customer complaints to monitor customer complaint trends and maintain compliance to complaint system.
- Investigate/analyze in-house and field failures (returns) and monitor quality trends. Propose and implement possible solutions/improvements utilizing the Corrective and Preventive Action (CAPA) system.
- Initiate supplier corrective actions and assist Purchasing to continuously improve supplier quality and enhance supplier relationships.
- Initiate, review, and approve Engineering Change Orders (ECO), Deviation Authorizations, Qualification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures.
- Design and/or specify inspection and testing procedures/systems to ensure products conform to specifications and quality standards.
- Initiate, review, and approve disposition for Nonconforming Product.
- Participate on product development teams, including developing Quality Plans and Risk Management Plans.
- Interface with personnel from all areas of the company to foster improved quality, reduced cost, and process improvement.
Required Qualifications and experience
- Bachelor Degree in Engineering Discipline
- At least 4-5 years Engineering experience in FDA-regulated industry
- Performance of root cause investigation (use of investigation tools (fishbone, 8D) a plus)
- Above average written communication skills
- Ability to work well independently and as part of a team
- Ability to analyze information from regulations, SPC charts, data tables, diagrams, and blueprints
Compensation
This position is for a one year contract, however there is potential for extension or conversion. This medical device provider is very eager to hire and encourages all interested applicants to apply as soon as possible. Do not hesitate to apply today.