Sr Quality Engineer

Let's do this. Let's change the world. In this vital role you will act as the Quality Engineering representative on multi-functional teams, employ quality principles and company's procedures including but not limited to the areas of device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development and lifecycle management of final product align with dynamic global regulations and standards.

The Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercialization. In addition, this role will also support various aspects of the product lifecycle including complaint investigations, expansion and transfer of products to new manufacturing sites, inspection readiness activities, and platform support and improvements.

• Provide Quality technical expertise, Quality oversight, and serve as a single point of Quality contact for combination and non-combination products associated with final product activities.

• Ensure program alignment and proper 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 related to life cycle management of commercial programs.

• Train and educate key functional partners and management on combination product requirements, standards and regulations

• Contribute to content and review of regulatory submissions and RTQs, and support audits and inspections for associated projects related to life cycle management of final product programs

• Scope may include a wide range of products, including but not limited to vial, prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, electromechanical on-body injector systems, and accessories.

• Plan and lead continuous improvements to the quality processes related to devices, combination product, assembly, labeling and packaging.

• Provide independent design review for other programs

• Provides quality oversight of the development, qualification, validation, transfer and maintenance of physical test methods including sample selection

• NOTE: This role may require working in shifts or extended hours within the same shift

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

Basic Qualifications:

• Doctorate degree OR

• Master's degree and 4 to 6 years of Quality experience OR

• Bachelor's degree and 6 to 8 years of Quality experience OR

• Diploma and 10 to 12 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 oversee multiple medium complexity projects simultaneously

• Working knowledge 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 successfully manage workload to meet 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 Decision, Advice and Inform (DAI) principles

• Understanding of industry requirements/expectations of a Quality Management System (QMS)

• Understanding of the applicable manufacturing/testing processes (i.e. Active Pharmaceutical Ingredient, Drug Substance, Drug Product, Packaging, Device manufacturing processes) Execution 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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.