Date Posted: 10/29/2024
Hiring Organization: Rose International
Position Number: 473565
Job Title: Senior Quality Engineer
Job Location: Lake Forest, CA, USA, 92630
Work Model: Onsite
Shift: 8-5
Employment Type: Temporary
Estimated Duration (In months): 24
Min Hourly Rate($): 60.00
Max Hourly Rate($): 66.00
Must Have Skills/Attributes: Healthcare, JIRA, Medical device, Microsoft PowerPoint, MS Excel, MS Office, MS Project, Quality Engineer, SharePoint, VISIO
Job Description
Required Education:
• Bachelor's Degree in an Engineering, Computer Science, Mathematics, Physical Science discipline, or equivalent years of directly related experience
Preferred Qualifications/Skills/Experience:
• Excellent verbal / written communication, with the ability to work effectively in cross-functional teams
• Strong knowledge of cloud platforms, cloud infrastructure management, change requests and software release deployment
Required Skills:
• Minimum 3 years' experience in Quality Operations/ Manufacturing/ Engineering/ Field Service in relevant GMP industry
• Experience with regulatory standards in the medical device industry, including FDA, ISO 13485, IEC 62304, HIPAA and GDPR
• Experience with MS Office, Excel, PowerPoint, Visio, MS Teams, SharePoint, JIRA, MS Project or other Project Management tools
The Sr. Quality Engineer – Global Technical Service is responsible for development, modification, application and maintenance of quality standards and processes applicable to Technical Services. Collaborates with Global Technical Service, Field Service, Cloud Operations and Digital Health teams to ensure quality standards are in-place and applied in respective operational environments. This position will primarily support Client’s cloud products.
Major Accountabilities:
• Collaborates on development and refinement of Global Technical Service and Digital Health processes to streamline operations and enhance compliance and operational efficiencies. Ensures performance and quality of products conform to established standards and agency guidelines resulting in exceptional customer experience
• Champions technical investigations of product and process quality issues. Ensures corrective measures comply with applicable standards and support high-level product performance requirements
• Leads development and provides guidance on equipment, process, and software verification and validation
• Work closely with product development, cloud operations, and DevOps teams to ensure high-quality releases and seamless integration of new features
• Develops methodology to measure key compliance and quality metrics for Global Technical Service
• Collaborates with Cloud Operational organization to develop and review operational change requests
• Monitor and analyze key performance indicators (KPIs) related to quality performance and identifying opportunities for improvement
• Leads development of post-market data and trending analysis for Digital Health and supports documentation related to product complaints - **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
I believe the best thing that Rose HR has going for it is the incredible responsiveness. Everyone is very quick to reply to any concerns, and contacts the contracted employees very quickly and efficiently.
Kevin, Consultant
It is a great pleasure being a part of the Rose International Team.
Toni, Consultant
I am very happy with the Rose International, and the professionalism of the employees.
Robin, Consultant
It was great working for Rose International. Everyone was extremely helpful.
Rosann, Consultant
Rose International was not only attentive and responsive, but they were very professional and helpful whenever I called or needed any assistance.
Diane, Consultant
EMPLOYEE COMMENTS