Packaging/Medical Device Quality Specialist

Description du poste

Join CSL Behring as a key QA Associate for combination products. Embrace a collaborative and innovative work environment with excellent benefits. Tasks Ensure compliance with FDA and EU MDR regulations for product development. Support quality activities throughout the product lifecycle, from design to post-market. Conduct audits and monitor vendor performance to uphold quality standards. Skills Bachelor’s degree in engineering or life sciences; 3 years of relevant experience. Strong knowledge of medical device regulations and quality systems. Effective communication and problem-solving skills. About the job As part of the Quality for Combination Products and Medical Devices (CP/MD QA) department, the Combination Product and Medical Device and Packaging QA Associate represents Quality in global teams involved in the design, development, manufacture, and regulatory approval of CSL combination products. These products include medical device constituent parts developed to enable convenience, monitoring, compliance, and effective outcomes for patients. This role ensures new product development activities for CSL combination product projects follow a 21 CFR Part 4-compliant quality system. The role serves as a subject matter expert on medical device and combination product requirements in accordance with FDA and EU MDR regulations, ISO standards, and industry best practices, with an emphasis on the Design Controls process. The position supports quality-related activities throughout the product lifecycle from concept through industrialization and post-market support, collaborating with multiple global functions and manufacturing sites. Main Responsibilities and Accountabilities Serve as Medical Device and Packaging QA Associate on assigned combination product development projects. Work with project leaders and internal/external team members to ensure design and development work meets applicable FDA, EU MDR, and other global regulatory requirements. Ensure design teams follow the Design Controls process and use appropriate quality engineering techniques (e.g., risk analysis, statistical data analysis, sampling plan development). Ensure external medical device development and manufacturing partners meet CSL standards and criteria. Support vendor management activities by participating in audits; reviewing quality and/or development agreements; and monitoring vendor performance. Provide regular progress reports and escalate potential risks related to the Quality System and/or project status to Quality management and stakeholders. Assist with development and implementation of a quality system compliant with 21 CFR Part 4, MDR, and other global requirements. As assigned, propose improvements to existing processes; update SOPs/WIs/Forms; and develop and conduct training on modified processes. Stay abreast of changing regulatory requirements for medical devices and combination products. Maintain systems/databases related to combination products, as assigned (e.g., Applicable Standards List, vendor certificate database, test method validation log). Conduct root cause analysis and problem-solve issues, providing recommendations. Education Bachelor’s degree in mechanical engineering, biomedical engineering, life sciences, or a relevant discipline. Experience Minimum 3 years of experience as a quality, packaging, engineering, or manufacturing professional in the medical devices or combination products field. Candidates with pharmaceutical, biotech, MedTech, or other related backgrounds may be considered. Competencies Working knowledge of medical device and combination product regulations and requirements, including (at minimum) 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, EU MDR, relevant FDA guidance, relevant standards, and their application in a compliant QMS. Minimum 2 years of practical experience in medical devices R&D Quality, including design controls; new product development life cycle; requirements specifications; risk management (including FMEA); verification and validation (V&V); usability/human factors studies; DHFs; and design transfer. Effective communication and collaboration skills. Assertiveness. Problem-solving skills to identify and resolve issues in a timely manner. Planning and organization skills to prioritize work activities and use time effectively. Preferred: Experience developing drug-delivery combination products. Plus: Experience with products that include embedded software, mobile/web apps, and other connected health solutions. Was wir bieten Wir möchten, dass Sie sich bei CSL wohl fühlen. Das ist wichtig und Sie sind es auch. Erfahren Sie mehr darüber, was wir bei CSL bieten . Über CSL Behring CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring . CSL soll so vielfältig sein wie die Welt, in der wir leben Als globales Unternehmen mit Mitarbeitenden in über 35 Ländern steht CSL für Vielfalt, Fairness und Inklusion. Erfahren Sie mehr über Vielfalt, Fairness & Inklusion bei CSL. Machen Sie mit Ihrer Arbeit bei CSL einen Unterschied!