Full time
Vertex Pharmaceuticals
Boston, MA, USA
This role will report to the Associate Director of Operations Quality and focus on the design and development of clinical and commercial Class II devices. The successful candidate will join the Quality Team and work closely with Product Development, Quality Control, Regulatory Affairs, and Manufacturing Functions, as required. The position will be located in Boston, USA. Key Responsibilities and Experience: Provides quality assurance support in the design and development of combination medical device products, facilitating the application of design controls and risk management. Supports Design History File establishment, creation, approval, and maintenance Supports Design History File audits at Phase Gates to ensure product development projects comply with applicable design control regulations (21 CFR 820) and company policies and procedures. Reviews and approves design documentation including, but not limited to, verification and validation methods, test plans,...

