Amgen

Sr Quality Engineer - Early Development Quality

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jul 17, 2019
Ref
R-78770
Required Education
High School or equivalent
Position Type
Full time
The Sr. Quality Engineer - Early Development Quality is accountable for providing advice and oversight to programs developing technologies for medical devices and combination products in early development phases, i.e. before Design Controls entry. The Sr. Quality Engineer will be advising teams on initiating documentation for later inclusion in the Design History File and for advising on structure and systems within good engineering practices. Responsibilities will include providing quality advice on risk identification, mitigation development, requirements structuring and problem solving in the technology feasibility process. This role will provide support for Human Factors activities for combination products in early development and non-combination final products in the pre-pivotal phase.

The Sr. Quality Engineer will be part of the FPT Quality - Early Development team which is accountable for providing quality advice to the early development programs within Final Product Technologies. We provide oversight and advice on medical devices and combination products, including primary container systems, drug delivery technologies, manufacturing and packaging processes.

Key responsibilities:
  • Responsible for providing quality advice to programs within Early Development, which may include development of new technology or new device concepts. Development activities may be conducted by Amgen or partner organizations.
  • Supports low to moderate complexity development programs.
  • Provides quality oversight of deliverables intended for further development and inclusion in Design History File.
  • Provides input to structure and systems (e.g. documentation management and requirements development) within good engineering practices to inform Quality by Design thinking.
  • Collaborates with process owners to integrate new requirements into the QMS due to novel technologies.
  • Provides quality advice including risk identification, mitigation development and problem solving in the technology Feasibility process (i.e., T-Milestones).
  • Collaborate with FPTQ Product Complaints to gather information on existing or prior complaints to provide quality technical expertise on early development projects.
  • Interface with PQLs during drug delivery device feasibility.
  • Collaborate with FPT on implementation plans in alignment with applicable guidance, regulations, and standards to enable future compliance as projects enter into design controls.
  • Provides support for Human Factors Activities for combination products in early development and non-combination final products in the pre-pivotal phase.


Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Manufacturing, Quality or Engineering experience

OR

Bachelor's degree and 5 years of Manufacturing, Quality or Engineering experience

OR

Associate's degree and 10 years of Manufacturing, Quality or Engineering experience

OR

High school diploma / GED and 12 years of Manufacturing, Quality or Engineering experience

Preferred Qualifications
  • 5+ years of experience in development, quality, or manufacturing in medical device or combination product industry
  • 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)
  • Working knowledge of technical standards (e.g., ISO 11608, ISO 10993 ISO 23908, IEC 60601)
  • Experience with assessment of potential vendors, partners, and suppliers
  • Experience with ideation and concept development, good engineering practices for testing and documentation, technology evaluation
  • Experience with device or combination product manufacturing equipment and processes.
  • Able to successfully manage workload to timelines
  • Familiarity with basic project management tools
  • Understanding of industry requirements/expectations of a process based QMS
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Ability to travel +/- 20% of time to domestic and international Amgen sites


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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