Sr Quality Engineer

Career Category

Quality

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. 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

What you will do

In this vital role, you will be accountable for advice to, and oversight of, technical aspects in design control and transfers. This role will also be a single Quality point of contact for device design and related issues in the development of combination and non-combination products. You will ensure that Quality Systems identified for design and development of devices and combination products are appropriate and compliant for pre-commercial development activities. Manage low to moderate complexity programs with minimal direction. Provide input on accurate quality resource balancing on project(s) as required.

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. Work multi-functionally with individuals and project teams to ensure success of development project efforts.
• Provide guidance to the Design and Development Plans for projects, and review and approve relevant final product Design Control documentation.
• Actively participate and contribute to applicable Design Control Stage Design Reviews and Technical Design Reviews.
• Represent CPOQ Development Quality and participate in onsite supplier due diligence visits, as needed.
• Contribute to content and review of regulatory submissions and RTQs by collaborating to develop complete formal written responses.

What we expect of you

The Quality Engineering professional we seek is a candidate with these qualifications.

Basic Qualifications:

• Doctorate degree
• Master’s degree and 2 years of Quality experience
• Bachelor’s degree and 4 years of Quality experience
• Associate’s degree and 8 years of Quality experience
• High school diploma / GED and 10 years of Quality experience

Preferred Qualifications:

• 5+ years of quality and manufacturing experience in biotech or pharmaceutical industry (device experience a plus)
• Bachelor’s Degree in a Science Field
• Ability to supervise multiple medium complexity projects simultaneously
• Solid understanding of quality engineering and/or mechanical engineering
• Familiar with final products including applicable guidance, regulations, and standards

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.