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.
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.
Bachelor’s degree in mechanical engineering, biomedical engineering, life sciences, or a relevant discipline.
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.
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.
