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Principal Quality Engineer
STARLIMS provides leading Laboratory Information Management Systems (LIMS) solutions that have served customers around the world for over 30 years. STARLIMS solution suite helps to improve the reliability of laboratory sampling processes, manage complex testing workflows and analytical methods, support compliance with global regulatory requirements and industry standards, and provide comprehensive reporting, monitoring, and analysis capabilities. With multiple support centers across the globe, STARLIMS solutions are used in labs across multiple industries and disciplines including pharma & biotech, life sciences, food & beverage, manufacturing, petrochemical refineries and oil & gas, chemical, public health, forensics and environmental offering an influx of global career opportunities.
The Principal Quality Engineer role is responsible for leading and participating in projects involving the design, validation and product release of complex software applications; systems or processes. This role will conduct quality-related activities to deliver consistent, high-quality documents, services, products and processes. This individual also ensures compliance with worldwide regulatory expectations/requirements.
The Role
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Performs assignments of a very complicated or difficult nature requiring a high degree of technical competence.
- Plans, organizes and conducts technical projects.
- Consolidates results of design elements of major projects for purpose of design review.
- Uses engineering principles to conduct technical investigations involved with the modification of software or process specifications and requirements.
- Conceives and plans projects to explore product or process problems; defines and selects new concepts and approaches to the design or development of new or improved products or processes
- Assesses the impact of a change on field and process performance and customer expectations worldwide.
- Understands and assesses the impact of a change on the safety and efficacy of a software product or device
- Applies the results of reviews of literature and current practices to the solution of current problems.
- Forms and suggests ideas to support the strategic technical direction of the area.
- Integrates multiple project plans.
- Establishes and reviews complex plans for multiple activities, projects or plans highly complex personal projects.
- Monitors and takes corrective action for processes and systems.
- Creates efficient protocols for validation of complex system functions and defines validation process.
Experience
- Progressive work experience in medical devices, LIMs, informatics or software development experience desired.
- Previous experience in product development projects with implementing design control processes by driving reviews and deliverables is required.
- Preferred experience with ISO 13485, 9001, 27001, and 62304 or similar ISO/IEC’s
Education
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Bachelor’s Degree in Engineering or science discipline
Compensation
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The candidate will receive a competitive compensation and a benefits package
If you are seeking a revolutionary opportunity to stay ahead of the innovative curve whilst satisfying an evolutionary approach, we want to hear from you!