Sr Quality Engineer

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Sr Quality Engineer

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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 transfers. In addition, this role will be a single Quality point of contact for device design and related issues in development of combination and non-combination products. Ensures that Quality Systems identified for design and development of devices and combination products are appropriate and compliant for pre-commercial development activities. Manages low to moderate complexity programs with minimal direction. Provides input on accurate quality resource balancing on project(s) as required.

Reviews and approves Design History File (DHF) content and user documentation and assessments throughout the design and development lifecycle, including content from suppliers and partners. Participates in development of final product requirements. Approves device components and final product or the device constituent of a combination product specification as part of development program.

Establishes the quality requirements for development process to transfer design. Participates in technical aspects of problem-solving, complaints, and other investigations in relevant design control phases. Participates in non-design control investigations on an as needed basis.

Responsibilities:

• Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non-combination products associated with Combination Product Operations 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 mentorship on documentation structures crafted during development activities. Responsible for identifying accurate 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 guidance to the Design and Development Plans for projects, and review and approve relevant final 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 specifications (developmental), PCS 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 Design Control Stage Design Reviews and Technical Design Reviews. Also 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 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 accurate linkages within the Design and Development Plans, Risk Management Documentation, and Control Plans Provide oversight and review of Human Factors Engineering (HFE) Protocols and Reports, as well as onboarding and auditing HFE suppliers.

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What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Qu