Sunrise Systems, Inc. · 17 hours ago
Quality Engineer
Sunrise Systems, Inc. is a company focused on quality engineering methodologies and practices. They are seeking a Quality Engineer to develop and maintain quality systems and support product development while ensuring compliance with internal and external requirements.
Responsibilities
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Lead 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
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Improve supplier quality performance for assigned suppliers via Part Quality Plan (PQP) implementation. Communicate, clarify and facilitate supplier Part Quality Plan (PQP) submissions, as well as conduct PQP review and approval for purchased products
Approve supplier selection through robust qualification processes, including supplier audits
Assure supplier compliance to Quality Management System (QMS) and regulatory requirements
Assure Corrective and Preventive Action (CAPA) plans are developed and executed at assigned suppliers in compliance with CAPA process
Qualification
Required
Bachelor's degree
3-5 years of experience
Effective problem solving, root cause analytical skills to lead and influence others to drive change
Bachelor's Degree in an engineering or technical discipline (or non-technical degree with 5 years of experience in manufacturing, engineering or quality assurance
Minimum 3 years' experience in manufacturing, engineering design, quality assurance or regulatory assurance
Preferred
ASQ Certified Quality Engineer or CQA Certified Quality Auditor
Demonstrated knowledge of Quality Management System tools and continuous improvement methodologies
Demonstrated supply quality experience within the medical device industry
Company
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.