DEKA Research and Development is searching for a Quality System Implementation Analyst to join our growing Quality team and be at the forefront of driving quality excellence! We are seeking a highly skilled and motivated Quality Systems Implementation Analyst to design, develop, and implement robust modules in DEKA's eQMS (Intellect system). The ideal candidate will analyze organizational needs, collect and process data, and create customized solutions that align with business goals and improve operational efficiency. This role requires strong collaboration across departments, technical expertise, and the ability to manage projects from start to finish.
As a Quality System Implementation Analyst, some key responsibilities supporting DEKA's eQMS will include:
- Analysis: Conduct stakeholder interviews to identify use cases and analyze current tools and workflows. Collect and analyze data to support business needs, providing insights for workflow improvements and data-driven decision-making.
- Design: Design and develop modules in the Intellect eQMS system, creating workflows and process flows for optimal functionality. Document system architecture and operational procedures to ensure clarity and future scalability. Translate technical requirements into system configuration changes.
- Implementation: Drive the deployment of the eQMS by configuring applications and system workflows, and integration with existing workflows. Assist with data migration and transformation projects, ensuring that new modules align with business requirements.
- Test and Validation: Develop and execute comprehensive test cases to verify system functionality. Conduct validation to ensure all systems meet regulatory and business standards.
- Maintenance: Provide ongoing technical support and troubleshooting to address any system issues. Perform routine updates and system optimization to ensure data security, system integrity, and continuous performance improvements.
- Collaboration: Collaborate with cross-functional teams to align system solutions with business objectives. Communicate technical challenges and solutions clearly to both technical and non-technical stakeholders, fostering teamwork and problem-solving.
To be successful in this role as a Quality System Implementation Analyst, you will need the following skills:- Bachelor's degree in Computer Science, Information Systems, Engineering, or a related field
- Required 5+ years in an analyst role, with a focus on building custom database integrations
- Preferred 2+ years' experience in application development, preferably within a regulated industry (e.g., medical devices, aerospace, defense, etc.)
- Experience implementing quality or process management systems (e.g., Salesforce, Intellect, ETQ, Veeva)
- Experience with Business process configuration in cloud-based enterprise applications (medical device eQMS experience preferred)
- Experience with programming languages (e.g., SQL, MySQL, Oracle, Python, Java, C#)
- Experience with data analysis, workflow design, and the ability to create technical documentation and system design specifications
- Experience building and maintaining system reports from data sources within the eQMS system and from company-wide digital infrastructure
- Strong problem-solving skills, attention to detail, and the ability to work in a collaborative environment
- Preferred working knowledge of Quality Management Systems (QMS) and regulatory compliance (FDA, ISO 13485, etc.)
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