Quality Specialist
vor 4 Wochen
Job description
As the Quality Specialist, you will play a pivotal role in ensuring the highest quality standards for our active medical devices, classified as class II. Your expertise will contribute in establishing and maintaining a robust Quality Management System (QMS) in compliance with ISO and 21 CFR Part and applicable regulatory requirements. Your guide will contribute to foster a culture of quality and excellence where every team member contributes to upholding our commitment to product safety and effectiveness and regulatory compliance.
Responsibilities:
Coordinate activities to develop and maintain our Quality Management System (QMS) for class II medical devices, complying to ISO and 21 CFR requirements and applicable regulations/programs (e.g., MDR, FDA QMS Regulation, MDSAP) Develop, implement, and sustain comprehensive quality assurance procedures. Provide quality guidance to cross-functional teams, aiding and training them in developing and maintaining QMS procedures relevant to their respective responsibilities. Coordinate and actively participate in quality and regulatory inspections, adeptly reporting and contribute to addressing any quality/regulatory related issues that may arise. Coordinate the regular assessment and continuous improvement of the efficacy of our QMS through meticulous metric analysis and audits. Conduct internal audits and coordinate external audits of suppliers and contract manufacturers to verify compliance with quality and regulatory requirements. Support development efforts, particularly by reviewing engineering testing (such as software and electrical safety), to ensure adherence to compliance standards like IEC and IEC -1. Mentor the team, inspiring them to achieve and uphold quality objectives consistently.
Your profile
Bachelor's or master's degree in engineering, life sciences, quality or regulatory affairs, or a related field. A minimum of 3 years of hands-on experience in Quality Systems Management, encompassing the entire lifecycle of medical devices. Familiarity with ISO , and FDA 21 CFR Part , is essential. Proven experience in internal and external audits and adeptness in supporting quality and regulatory inspections. Prior exposure to CE marking or FDA clearance/approvals for class II medical devices is highly desirable. A collaborative team player, enthusiastic about working for a dynamic start-up company, proficient in communication, peer leadership, and creative problem-solving. Exemplary attention to detail and the ability to effectively prioritize tasks in a dynamic and fast-paced environment. Advanced training in design quality, quality control or manufacturing quality is considered an asset. Able to communicate on all stakeholder levels and coordinate with top management team for reporting and execution of quality/regulatory activities Strong interest in interdisciplinary work, willingness to dive into new topics and understand medical requirements. Good interpersonal skills, teamwork, multi-cultural compatibility. Fluency in English, German is desirable-
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