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Job Analysis:
The role of the eQMS Specialist primarily targets an expert in embedded and firmware systems testing, especially in the context of IoT applications. The fundamental purpose of this position is to ensure high performance and reliability of innovative medical devices through thorough automation testing frameworks. Key responsibilities include leading the automated testing strategy, which translates to championing best practices in testing and integrating both hardware and firmware systems to meet compliance and performance standards. The candidate must navigate complexities such as designing HIL testing setups and maintaining CI/CD pipelines, suggesting a high degree of technical acumen and problem-solving abilities. Success in this role would not only involve executing automated test strategies but also collaborating across teams to identify and resolve issues efficiently, thereby contributing to the swift delivery of quality medical devices. The impediments faced could vary from coordinating with cross-functional teams to aligning with regulatory requirements in a highly dynamic industry.
Key skills sought for this position encompass both hard skills, such as proficiency in C and Python programming, familiarity with CI/CD tools, and experience with HIL testing, as well as soft skills like effective communication to articulate complex technical concepts. A Bachelor’s degree in engineering is expected to lay the foundational understanding required for this role, while relevant industry experience and knowledge of regulatory environments like FDA regulations further enable the candidate to function effectively. Moreover, the candidate must exhibit strong judgment and autonomy, particularly in decision-making related to the testing strategy and implementation to optimize product deliveries while ensuring compliance. Performance expectations would center around the efficacy and efficiency of the testing processes, measured through the reduction of bugs and validation issues, while also adhering to timelines for project deliverables.
Company Analysis:
Systems Ally operates at the nexus of medical devices and technology, signifying a solid foothold in innovative solutions within highly regulated industries such as pharma and biotech. As a leader in providing global workforce solutions, the company is positioned to influence product quality and safety through its commitment to manufacturing excellence and regulatory compliance, which the eQMS Specialist's role directly aligns with. The organization seems to balance between being a traditional player while innovative enough to adapt to market changes, which should resonate with a candidate who appreciates both stability and forward-thinking.
In terms of culture, Systems Ally appears to promote an environment of continuous improvement and collaboration across teams—attributes that would impact a candidate’s day-to-day work significantly. Engaging in cross-functional collaboration implies that the candidate must thrive in a flexible, results-oriented culture, which may also be fast-paced given the high stakes involved in medical technologies. This role may place the eQMS Specialist in a visible position within the organizational hierarchy, potentially reporting to senior engineering management or a direct supervisor while working closely with hardware, software, and quality teams.
The strategic alignment of this role is pivotal; it’s not merely a backfill but signals Systems Ally’s commitment to bolstering its testing processes amid evolving product lines. The specialist will play a key role in maintaining high standards of quality assurance, thereby enhancing operational effectiveness and ultimately supporting the company's mission to drive innovation and safety in healthcare solutions.