Quality Systems Analyst

As a Quality Systems Analyst at Idoven, you will be responsible for maintaining the Quality Management System (QMS) to ensure compliance with various standards such as ISO 13485 and IEC 62304. Your role will involve managing customer feedback and complaints, conducting supplier quality evaluations, preparing for internal and external audits, and leading quality improvement initiatives. Additionally, overseeing document management processes and contributing to risk management documentation will be key parts of your responsibilities.

To qualify for the Quality Systems Analyst position at Idoven, candidates must have a Bachelor’s degree, with a Master’s degree preferred. A minimum of 2 years of experience in Quality Assurance or Quality Systems Management within a regulated industry is essential, ideally in medical devices. Familiarity with quality system standards and regulations such as ISO 13485, EU MDR, and FDA 21 CFR 820 is also required. Candidates should possess strong analytical skills and the ability to collaborate cross-functionally.

An ideal candidate for the Quality Systems Analyst role at Idoven should demonstrate a solid understanding of quality system standards and regulations, an analytical mindset with excellent organizational skills, and the ability to identify and implement process improvements effectively. Experience managing Non-Conformance and CAPA processes, as well as strong collaboration skills, are also highly valued. Fluency in English is mandatory, and Spanish is a plus!

Idoven is committed to personal and professional growth, offering extensive learning and development opportunities, along with a dedicated training budget. As a Quality Systems Analyst, you will have access to various resources and programs aimed at enhancing your knowledge and skills, keeping you updated on industry changes and best practices. This supportive environment encourages ongoing education and professional advancement.

At Idoven, Quality Systems Analysts enjoy a range of enticing benefits, including unlimited remote working flexibility, health insurance, and access to wellness programs such as Wellhub (Gympass). The company offers competitive remuneration, 23 vacation days, and special days off for birthdays and holidays. Regular team events, a positive work culture, and state-of-the-art technology also contribute to a rewarding work experience.

Certainly! In my previous roles, I was extensively involved in the development and maintenance of Quality Management Systems. I ensured compliance with the most relevant standards, such as ISO 13485 and DEA regulations. I believe my hands-on experience and understanding of quality processes will align well with the requirements of a Quality Systems Analyst at Idoven.

I prioritize my tasks by assessing the urgency and impact of each project. I often use project management tools to create a detailed schedule that facilitates tracking progress. Communication with team members and stakeholders is also critical, ensuring that everyone is aligned, which helps me to effectively manage multiple projects without sacrificing quality.

When conducting audits, I adhere to a structured approach. Before the audit, I prepare thoroughly, reviewing past audit reports and current compliance documents. During the audit itself, I focus on active listening, noting any discrepancies or areas for improvement, and asking pertinent questions. Afterward, I compile a detailed report to communicate findings clearly and provide recommendations based on best practices.

Handling customer feedback in a quality assurance role requires a proactive approach. I actively seek feedback through surveys or direct communication and ensure that all feedback is documented and analyzed. By classifying feedback into trends, I can identify areas needing improvement and work on solutions. It's essential to follow up with customers, letting them know their concerns have been addressed, which also fosters trust.

I have considerable experience managing Non-Conformance and Corrective and Preventive Action (CAPA) processes in regulated environments. My process typically begins with thorough documentation of the issue, followed by root cause analysis. I then develop an action plan to address the non-conformance and introduce preventive measures to avoid recurrence. Continuous monitoring during implementation is vital to ensure effectiveness.

Risk management is a crucial aspect of quality systems—it helps identify potential hazards and mitigate them before they can impact product safety and performance. In my experience, I have contributed to maintaining risk management documentation, conducting risk analyses, and using tools such as Failure Mode and Effects Analysis (FMEA) to evaluate risks systematically. This proactive approach aligns well with the objectives of Idoven.

I have worked extensively with regulatory compliance related to quality systems in the medical device industry. This has included ensuring adherence to ISO standards and FDA regulations. I am adept at interpreting complex regulatory requirements and have experience preparing for both internal and external audits to validate compliance, which I believe is essential for a Quality Systems Analyst role at Idoven.

Promoting a culture of quality begins with clear communication and leadership. I ensure that quality objectives are visible and understood by everyone on the team. Regular training sessions and sharing insights on best practices help foster accountability. Encouraging open dialogue on quality-related topics boosts team engagement and creates a collaborative atmosphere where quality is everyone’s responsibility.

I have utilized various tools and software to streamline quality assurance processes, including document management systems, risk assessment software, and audit management tools. Familiarity with software such as QMS platforms enables me to effectively track compliance, manage documentation, and facilitate continuous improvement initiatives. I am always open to adopting new technologies that enhance efficiency.

I was drawn to the Quality Systems Analyst position at Idoven because of the company’s innovative approach in the HealthTech space and its commitment to quality and compliance. The opportunity to work on cutting-edge AI-driven medical solutions resonates with my passion for improving healthcare. I believe my skills and experience align perfectly with Idoven's mission and goals.