SRG is a global staffing and consulting firm and we are looking for a Quality Engineer for a 6 month contract in Irvine, CA.
The ideal candidate will provide support to the Quality Operations team to maintain compliance during the integration activities.
• Manage multi discipline groups for project execution and implementation
• Serve as an owner of the QMS integration activities for one of the client's sites.
• Responsible for the completeness of the integration activities; Create, review, and approve controlled documents on an electronic document control system.
• Coordinates and/or provides training to staff in Quality System documents, work instructions.
• Provides ongoing development and maintenance of training materials and records during integration activities.
• Review and assess QMS changes for completeness, accuracy, and effectiveness.
• Collaborate with the team to define and implement systems that enhance efficiency, productivity, and quality;
• Work towards resolving quality issues
• Ensure that procedures and processes are maintained and updated to be consistent with regulatory changes including the development of more efficient QMS processes and global QMS processes;
Minimum Qualifications, Skills, and Abilities:
• Bachelor’s Degree in Engineering.
• 5+ years of experience within the medical device space, R&D, regulatory or design development.
• Effective verbal and written communication skills; ability to write clear procedures
• Exhibit good problem solving and analytical skills
• Proficient in the use of Microsoft Office
• Knowledge in FDA QSR, ISO 13485 regulations
• Knowledge in Root Cause Analysis tools
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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