AbbVie

*Quality Engineer IV - Medical Device, Validation with Software

Employer
AbbVie
Location
Dublin, CA, United States
Posted
Sep 05, 2020
Ref
197067
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Job Description

Envision working with energetic colleagues and inspirational leaders. AbbVie is always striving to find top scientists to work at our Dublin site. Grow your career with the pharmaceutical and medical device industry leader!

Quality Engineer IV

An "ideal" candidate for this role is someone with sound knowledge of software controls in a medical device manufacturing environment."

Successful candidates will have the following types of experience:

This role is responsible for quality support for New Product Introduction (NPI) and Supplier Process Validations of Allergan manufactured products. You will be the expert responsible for providing guidance on Manufacturing Test Software and Equipment Validation Strategies

YOU WILL:
  • Be a trusted and expert partner. Responsible for driving continual process improvements in responsible areas of the business. Drive quality and manufacturing improvements to assure that processes are in a state of control. Develop and maintains effective relationships and integrate activities with other departments and suppliers. Review and approve changes made to product and processes and validation/qualification protocols and reports. Review specifications and design documents for manufacturing software tools and provide feedback.


  • Build bridges. You will be involved in supplier processes, including reviewing supplier validation protocols and reports, drafting and providing supplier validation protocols & reports, reviewing supplier pFMEAs and master validation plans, reviewing supplier tooling requirements. Work in conjunction with supplier quality Group to coordinate any Supplier Validation activities. Set up QA best practices to ensure that manufacturing software is developed and implemented with high quality. Work with internal customers and suppliers to ensure that process validation related non-conformances, failure analysis reports and deviations are appropriately investigated, documented, reviewed and approved.
  • Develop and implement quality workflows. Responsible for drafting and/or updating quality procedures for quality operations functions. Initiate and develop standards and methods for inspection, testing, and evaluation as necessary. Assure product compliance to specifications through implementation of inspection criteria, procedures and training.


Qualifications

YOU BRING:
  • Bachelor's degree in engineering or other technical discipline, or advanced degree in other disciplines, or equivalent experience.
  • Minimum of 2 years of quality engineering or equivalent experience in FDA regulated medical device manufacturing environment(s).
  • Experience working with medical devices with significant software controls and good understanding of software development life cycle desired.
  • Experience with software development on Windows OS is
  • Proficiency in reading and interpreting mechanical drawings and GD&T.
  • Knowledge of QSR and ISO 13485.
  • Medical Device Auditor certification preferred.
  • Ability to travel up to 15 percent time.

LEADERSHIP SKILLS:
  • Excellence Focused
  • Boundaryless Mindset
  • Open and Authentic
  • Strategic Foresight


PDN2

Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.