Sr Quality Engineer

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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

Live

What you will do

Lets do this. Lets 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality Engineering professional we seek is a candidate with these qualifications.

Basic Qualifications :

Doctorate degree

Masters degree and 2 years of Quality experience

Bachelors degree and 4 years of Quality experience

Associates 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)
• Bachelors 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 (e.g., MDR, ISO 14971, ICH Q9, ICH Q8, ICH Q10, ISO 13485, EU Annex 1, 21 CFR parts 4, 820, 210 and 211)
• Prior experience working as part of a combination product launch team
• Able to optimally manage workload to timelines
• Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership
• Experience driving decision making by using DAI principles
• Understanding of industry requirements / expectations of a QMS
• Understanding of the applicable manufacturing / testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Delivery of technical standards, internal requirements, and regulations
• Comfortable with both drug and device terminology
• Ability to travel + / - 15-20% of time to domestic and international Amgen sites

Thrive

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 including :

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.