Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.
abbvie.
com.
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Job Description
Purpose
AbbVie is the Legal Manufacturer for an Ambulatory Pump System delivering life changing therapy to APD patients.
This pump is currently in late-stage development and will go into commercial production upon approval in 2025.
AbbVie is looking for a person with a strong Quality Engineering background and extensive hands on electro-mechanical experience to join the cross functional team that is to bring this pump through development and into commercialization.
Responsibilities
Ensure that the Design History File is constructed in compliance with applicable Regulations for CE marked product and FDA registered product.
Responsible for Change Control of product designs improvements.
Ensuring that the Supplier makes pumps in a GMP compliant manner and to the agreed schedule.
Provide on-site support to the Supplier when required as well as the larger cross-functional team to identify ways to improve the assembly processes to reduce non-conformances and complaint rates.
Develop an in-depth knowledge of the pump and be the Quality Subject Matter Expert for the Pump operation and manufacture and provide Quality Engineering support through-out the life cycle of the Pump.
Key partner on Change Review Boards, Exception Review Boards and Complaint Reporting team.
Be part of the Core Team making regular reports to Senior Management on progress and issues.
Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Qualifications
Qualifications
Bachelor’s Degree in Engineering, relevant Life Science or other technical discipline.
7+ years of total combined experience.
At least 5 years in Quality Assurance Operations Management; 3 years in Operations, Research and Development or Consulting.
Electro-mechanical experience preferably with pump systems.
Knowledge of Design Controls and Software in a Medical Device preferred.
Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.
Additional Information
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
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