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Sr Quality Engineer

Employer
Amgen
Location
Cambridge, MA
Start date
Nov 16, 2021

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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Live

What you will do

Lets do this! Lets change the world!

As a member of Amgen's Commercial Quality group for drug delivery systems, the Sr Quality Engineer will provide quality engineering support for the maintenance of commercialized drug delivery devices, combination products, and non-combination products.

Responsibilities include leadership and participation in the implementation and maintenance of device/combination-product related design controls per FDA CFR 820.30, CAPA/RCA/Change Control projects, product complaints investigations, and other assignments as given.

This person will also help to ensure that the Quality Systems in place for Amgen products are appropriately scoped and followed. They will manage low to moderate complexity programs with minimal supervision.

This position collaborates with the Sr Manager Quality Engineering, FPTQ Commercial and is a liaison with other groups in Amgen as needed to support the programs.

Key Responsibilities
  • Provide Quality technical expertise, Quality oversight, and a single point of Quality contact for combination and non-combination products associated with Final Product Technologies activities.

  • Work multi-functionally with individuals and project teams to ensure success of commercialized product project efforts.

  • Provide quality guidance and documentation impact associated with commercial activities.

  • Responsible for identifying proper GMP or Non-GMP phase-appropriate documentation strategies and repositories required for the commercial life cycle management of medical devices and combination products to ensure compliance with applicable laws and Amgen Procedures.

  • Responsible for the maintenance of Design History files, Control Plans and Design Traceability Matrix.

  • Provide Quality oversight of Design Characterization, Verification and Validation activities associated with commercial product lifecycle management programs, ensuring alignment to all relevant regulations and standards (internal and external).

  • Represent FPTQ Commercial Quality and participate in onsite supplier technical support visits, as needed.

  • Contribute to content and review of regulatory submissions and responses to agency inquiries. Participates in audits and inspections.

  • Scope includes a wide range of medical devices (including prefilled syringes, needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, software as medical devices and on-body injector systems), combination products, and non-combination products.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.

Basic Qualifications:
  • Doctorate degree OR

  • Masters degree and 3 years of Quality experience OR

  • Bachelors degree and 5 years of Quality experience Or

  • Associate's degree and 10 year of Quality experience or

  • HS diploma / GED and 12 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 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, IEC 62366, ISO 14971, ISO 13485, 21 CFR parts 4, 820, 210 and 211)

  • Prior experience working as part of a combination product or medical device development or commercial team

  • Able to successfully handle workload to timelines

  • Ability to effectively negotiate, articulate, and defend a position after taking feedback from multiple sources

  • Ability to operate in a multi-functional team environment with site, functional area, and executive leadership

  • Experience driving decision making

  • Understanding of industry requirements/expectations of a QMS

  • Understanding of the applicable manufacturing/testing processes (i.e. Packaging, Device manufacturing, Device design, Verification, Device Validation, etc.)

  • Execution of quality systems for medical devices to 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

Competencies
  • Deep and broad understanding of quality processes for medical devices/combination products, including change control, design controls, risk assessment and management, and root cause analysis.

  • Medical device and combination product knowledge and understanding including functional knowledge of applicable guidance, regulations and standards to enable future compliance as projects enter design controls

  • Knowledge of quality engineering and device engineering

  • Demonstrated ability to analyze data, including knowledge and proficiency with basic statistics

  • Strong problem solving, trouble shooting, and analytical skills

  • Advanced technical writing skills

  • Able to innovate in a highly regulated environment

  • Ability to work optimally in global multi-functional teams and in a highly matrixed team environment

  • Able to overcome uncertainty or ambiguity to achieve goals

  • Able to motivate changes that lead to increases in efficiency demonstrating strong multi-functional relationships

  • Excellent verbal and written communication

  • Ability to lead and motivate a team

  • Strong Technical writing skills

  • Strong Critical thinking skills

  • Possesses a global mentality

Authority
  • Provides Quality guidance to final product commercial activities and deliverables

  • Quality approval of project related documents

  • Advises Product Teams and/or technical teams in collaboration with other quality leads

Thrive

Some of the vast rewards of working here

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

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

  • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

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

careers.amgen.com

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Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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