Principal Quality Engineer – Development Quality

Career Category

Job Description

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Principal Quality Engineer – Development Quality

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What you will do

Let’s do this. Let’s change the world. In this vital role you will be accountable for advice to, and oversight of, technical aspects in design control, and design and technical transfers. In addition, this role will be a single Quality point of contact for device design and related issues in development of devices and combination and non-combination products. Accountable for ensuring that Quality Systems for design and development of devices and combination products are appropriate and compliant for pre-commercial development activities. Independently manages high complexity programs with greater risk to the business including those which are novel or new to Amgen, including electromechanical, and/or internally developed. Responsible to represent CPOQ Development in external engagements. Provides guidance of proper quality resource balancing on project(s) as required, ensuring CPOQ resources are proactively managed. Reviews and approves Design History File (DHF) content and user documentation and assessments throughout the design & development lifecycle, including content from suppliers and partners. Participates in definition and development of final product requirements, in particular for specialized products. Approves device components and final product or the device constituent of a combination product specification as part of development program.

Responsibilities:

• Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non-combination products associated with Final Product Technologies activities.
• Attend development program meetings as required as part of program working teams.
• Work multi-functionally with individuals and project teams to ensure success of development project efforts.
• Provide guidance on documentation structures created during development activities.
• Identify proper GMP or Non-GMP phase-appropriate documentation strategies and repositories required for the design and development process to ensure compliance with applicable laws and Amgen Procedures.
• Provide feedback to the Design and Development Plans for projects, and review and approve relevant combination product Design Control documentation including (Design Input Documents, Risk Summary Reports, Verification Plans, Characterization Protocols and Reports, Design Validation/Qualification Protocols and Reports, Design Specifications, Trace Matrices, Design and Tech Transfer Plans, PLAN Specifications (Development), PCS device configuration specifications (qualified), PLAN component specifications (developmental), PCS component specifications (qualified), Create the Design Traceability Matrix, and provided review and approval for subordinate project plans and associated projects.
• Actively participate and contribute to applicable Technical Reviews and Design Control Phase Design Reviews.
• Provide Quality oversight of Design Characterization and Verification and Validation activities.
• Ensure alignment to all relevant regulations and standards based on the type of device under development.
• Represent CPOQ Development Quality and participate in onsite supplier due diligence visits, as needed, in support of supplier qualification and development as it relates to design control activities.
• Contribute to content and review of regulatory submissions and RTQs by collaborating to develop complete formal written responses. Participates in audits and inspections, is well prepared by owning relevant details that are supported by evidence and for associated projects.
• Scope may include a wide range of devices, including but not limited to prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and on-body injector systems.
• Development projects may include primary container, mechanical, electrical, and/or software as part of the system(s).
• Responsible for ensuring program alignment and proper linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans Provide oversight and review of Human Factors En