Sr Quality Engineer / Lake Forest, CA (Onsite)-24 months Contract - Suncap Technology, Inc.
Lake Forest, CA
About the Job
Title: Sr Quality Engineer – Cloud Application Services
Location: Lake Forest, CA (Onsite)
Duration: 24 months
Job Description:
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 ***'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.
Minimum requirements:
• Bachelor's Degree in an Engineering, Computer Science, Mathematics, Physical Science discipline, or equivalent years of directly related experience.
• The ability to fluently read, write, understand and communicate in English.
• Minimum 3 years experience in Quality Operations/ Manufacturing/ Engineering/ Field Service in relevant GMP industry. Medical Device or Healthcare preferred
• 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.
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
Location: Lake Forest, CA (Onsite)
Duration: 24 months
Job Description:
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 ***'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.
Minimum requirements:
• Bachelor's Degree in an Engineering, Computer Science, Mathematics, Physical Science discipline, or equivalent years of directly related experience.
• The ability to fluently read, write, understand and communicate in English.
• Minimum 3 years experience in Quality Operations/ Manufacturing/ Engineering/ Field Service in relevant GMP industry. Medical Device or Healthcare preferred
• 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.
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
Source : Suncap Technology, Inc.
