A Product Quality Engineer evaluates and tests products and manufacturing systems, to ensure that products are produced that meet quality and performance standards as well as safety and regulatory requirements. Develops product quality standards and monitors production and product testing.
Quality Engineer Katalyst Healthcares & Life Sciences - 4.0 Arlington, VA Job Details Contract 3 hours ago Qualifications Report writing Defect resolution root cause analysis Preventive action implementation Quality control preventive actions Corrective and preventive actions (CAPA) Technical report writing Medical device manufacturing facility experience Document review Biomedical regulatory compliance Quality control communication Product quality failure Documentation reviews Failure analysis
Full Job Description Summary:
Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
Provides leadership role on championing departmental or cross-functional engineering initiatives. Provides project direction, coaching, and mentoring for engineering and technical team personnel. Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Mentor for technical guidance for identifying and resolving quality issues. Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements. Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Requirements :
5+Years with
BS, 3 -4
Years with MS Ability to take work direction and work independently Medical device experience coordination and ownership, communicating with the contract manufacturer and BSC Quality/operations/design teams, supporting design changes activities and supplier corrective records, etc. CAPA Primary work assignments will be involving supporting our Quality systems and Quality operations for our hepatic artery infusion pump and accessories authoring post market surveillance report, periodic document reviews, experiencePost market surveillance Experience owning CAPA Root cause analysis experience
