Principal Device QA Engineer is an experienced Quality and Technical professional who develops and has stewardship of the overall device and combination product quality strategy to maximize the benefit and sustainability of Takeda's in-line products and to bring Takeda's pipeline products to a sustainable existence on the market.
- Drive quality life cycle management of commercialized device and combination products (DCP) to ensure timely release of products in compliance with all cGMPs, SOPs, clinical, device, and regulatory requirements.
- Execute/approve device CAPAs, deviations, complaint investigations, and incident escalations for DCP derived incidents.
- Support post market surveillance activities.
- Drive maintenance and improvement of assigned processes within DCP QMS and support all appropriate activities in preparation for DCP quality management review.
- Ensure robust Supplier Quality Management program for DCP suppliers, including auditing of suppliers, quality agreements, documentation and governance and management of the quality interface with responsibility for the ultimate release of DCP.
- Support activities for Clinical Evidence Review and Risk Management updates.
- Providing sustainable Device QA support for internal and external manufacturing, packaging, testing and release of DCPs.
- Drive launch readiness activities and support regulatory filings.
- Life cycle management of Takeda DCP portfolio for US and ROW.
- Participate on teams sustaining and/or improving DCP and responsible for living documents management (risk management, DHF, DMR, Technical File, specifications, etc.) in compliance with applicable regulations.
- Subject matter expert for assigned DCPs and product related QMS processes
- Participate on teams developing global policies and procedures for DCPs
- Ensures robust manufacturing, testing, and product review.
- Monitors and analyzes DCP quality performance to demonstrate levels of control, capability and compliance.
- Accountable for compliance of commercial and clinical DCPs including timely completion of vigilance assessment activities, investigation and associated incident escalation and CAPA activities
- Assessment and investigation of customer complaints.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor's Degree in BS in Engineering or equivalent technical discipline required, and at least 7 - 10 years of experience working with medical devices and/or combination products in a regulated healthcare industry, with a minimum of 5-7 years Quality Assurance and/or Quality Compliance roles;
- Expert knowledge of international regulations for Device and Combination Products with full understanding of European, International, and US requirements for Design Control, Supplier Management and Risk Management guidelines, Post Market Surveillance, CAPA, etc. primarily emphasis on ISO 13485:2016, MDSAP, ISO 14971, and 21 CFR Part 4, 820, 803.
- Experience with Class I & II & III sterile and non-sterile medical devices
- Experience with clinical development and regulatory filings
- Experience working with external manufacturing partners; assessing root cause analysis and effective investigation practices; strong operations background to ensure value added and effective quality operations; experience driving out inefficiencies and improving turnaround times; understanding of GDPs and global supply and distribution networks.
- Experience through interacting and collaborating with cross-functional global teams; project/program management and operational excellence preferred;
Desired: Advanced Degree; Experience working Pharma/Biotech/Device Quality functions preferred, Green Belt or Black Belt certification; Auditor certification. Experience with injection pens, infusion sets, and/or infusion pumps.