- Provide development support for Trackwise EQMS and other related QMS applications.
- Administer and maintain the functionality of the QMS, ensuring optimal performance and reliability.
- Collaborate with onshore teams and stakeholders to gather business requirements related to QMS functionalities, with a focus on Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
- Analyze and translate business needs into technical specifications for system enhancements.
- Develop and implement custom solutions and configurations to enhance the capabilities of the QMS in areas such as Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
- Develop and implement custom solutions and configurations to enhance the capabilities of the QMS, specifically in the development of interfaces between EQMS and SAP.
- Utilize SAP ABAP expertise to support the integration between the EQMS system and SAP.
- Collaborate with development teams to ensure seamless integration of QMS with other business systems.
- Ensure that QMS systems comply with relevant regulatory requirements in the medical device industry, especially in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
- Conduct periodic audits and assessments to verify adherence to quality standards.
- Provide training and support to end-users to ensure effective utilization of QMS systems.
- Troubleshoot and resolve user reported issues in a timely manner.
- Maintain comprehensive documentation for system configurations, changes, and upgrades, specifically in the context of Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions.
- Generate regular reports on system performance, issue resolution, and compliance metrics.
-
TalentBurst, Inc. Sunnyvale, United States ContractTitle of the role: Trackwise Business Systems Analyst and Developer · Duration: 6 months · Contract/possibility for conversions: NA · Onsite/Hybrid/Remote: Hybrid · Only Locals/Nonlocals can be submitted: Only Locals · Mode of interview: Zoom · No of rounds of interview: 3 · Job ...
-
EQMS Developer
1 week ago
V Technology Solutions LLC Sunnyvale, United StatesTrackwise EQMS Developer (Java Base Applications) · Sunnyvale, CA – Onsite · 8+ Years exp needed. · Trackwise EQMS Developer/Analyst in Sunnyvale, CA. Start date is 2/19 and will last 6+ months · 100% on site · Job Description: · We are seeking a highly skilled and experienced De ...
-
EQMS Developer
3 days ago
V Technology Solutions LLC Sunnyvale, United StatesTrackwise EQMS Developer (Java Base Applications) · Sunnyvale, CA – Onsite · All potential applicants are encouraged to scroll through and read the complete job description before applying. · 8+ Years exp needed. · Trackwise EQMS Developer/Analyst in Sunnyvale, CA. Start date ...
-
Trackwise QMS Analyst
1 week ago
Raise Sunnyvale, United StatesWe're Hiring Our key client in clinical robotics is looking for additional members for their team. We have a Business Systems Analyst III on the team. · Pay Rate: $92.59/hour on W2 · Work Type: Hybrid – Sunnyvale, CA Locals Only) · Duration: 6-month contract (with possible extens ...
-
Quality Assurance Manager
1 week ago
Actalent San Mateo, United States Full timeDescription: · • Ensures site quality oversight of commercial and/or development products at CMO's. · • Oversees the commercial and/or development implementation of the Quality strategy for Gilead development portfolio of products and/or across quality subfunctions. · • Partners ...
-
IT Business Applications Developer
4 days ago
Intuitive Sunnyvale, United StatesCompany Description · At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. · As a pioneer and market leade ...
-
Business Systems Analyst 3
1 week ago
V R Della Infotech Inc Sunnyvale, United StatesJob Description · Job DescriptionDescription: · IMPORTANT: Suppliers should not submit workers whose physical residence is within the following states due to Intuitive tax and operating entity structure: · Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, ...
-
Senior Manager, Quality Assurance
13 hours ago
Gilead Sciences San Mateo, United StatesFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - workin ...
-
Senior Manager, Quality Assurance
1 week ago
Gilead Sciences San Mateo, United StatesSenior Manager, Quality Assurance · United States - California - Foster City · Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and inves ...
-
Senior Manager, Quality Assurance
1 week ago
Gilead Sciences, Inc. Foster City, United States Paid WorkFor Current Gilead Employees and Contractors: · Please log onto your Internal Career Site $) to apply for this job. · At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – wor ...
QMS TrackWise Developer - Sunnyvale, United States - Intuitive Surgical
Description
Job Description
Primary Function of Position
Intuitive is seeking a highly skilled and experienced Applications Developer specializing in Quality Management Systems (QMS). This role will be responsible for supporting, developing, and administering Trackwise EQMS with a specific focus on Java based application development in Post Market Surveillance, Complaints Management, CAPA, Nonconformance, and Regulatory Submissions. Additionally, they will support the development of interfaces between the EQMS system and SAP.
Essential Job Duties
1. System Support and Administration:
2. Requirements Gathering and Analysis:
3. System Development and Customization:
4. Quality System Compliance:
5. User Training and Support:
6. Documentation and Reporting: