Posted in: Other in Nebraska | Posted: |
Job Description
About This Role
Biogen’s Product Development Quality function is looking to hire a Principal Device Quality Engineer (QE). This role provides a direct connection between the design and development of medical devices and combination products with the greater organization, ensuring compliant implementation of design in Biogen’s validated systems. Further, this role will be established as the SME for risk management and will be responsible for leading Lifecycle management programs, and post marketing commitments for combination products and standalone medical devices. This candidate is responsible for ensuring that the quality of product meets GMP standards, Biogen standards, ISO 13485, and ISO 14971 specifications and is compliant to the regulatory filing.
What You’ll Do
Primary QE oversight for early and late-stage device design/development and manufacturing deliverables. Core member of quality and design and development team representing QE perspectives. Oversee quality and Risk Management aspects of GMP activities for product manufactured and tested at Biogen’s CMOs. Manage the QA interface with manufacturing and testing partners to ensure on-time compliant manufacturing and testing.
Responsible for implementation of design in Biogen’s validated systems such as PLM, Track Wise, and Oracle.
Responsible for E2E QE support from design and development to commercialization, and process /analytical method validation as it relates to unit operations for the manufacture of product, including lifecycle management and Post-Marketing Commitments.
Ensuring that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control (21 CFR 820.30) and risk management (ISO 14971) requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses.
Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions.
Execute impact and risk assessments in response to product / quality system failures, investigations, and regulatory inspections.
Provide Device Quality expertise to influence and support decisions across the Biogen Supply Chain.
Support internal audits, external audits of CMOs and regulatory inspections at CMOs as needed.
Who You Are
The incumbent must forge strong relationships with both internal and external stakeholders, possess effective interpersonal, as well as strong verbal/written communications skills, and a collaborative spirit and ability to think outside of the box to influence and drive continuous improvement efforts. Thie ideal candidate must be comfortable working in a fast-paced environment with and minimal direction and ability to thrive in ambiguity as well as changing priorities.