at AbbVie in North Chicago, Illinois, United States
Job Description
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. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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.
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+ 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.
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+ Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ?
+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.?
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.?
+ This job is eligible to participate in our short-term incentive programs. ?
+ This job is eligible to participate in our long-term incentive programs. ?
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
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.
