Company DescriptionAbbVie'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 DescriptionKey Responsibilities
Ensure quality standards for manufacturing, servicing, warehousing, & distribution of Zeltiq manufactured products.
Lead & oversee quality operations, drive process improvements, & collaborate with cross-functional teams to maintain compliance & enhance overall quality of the product.
Work in a quality engineering FDA regulated Medical device manufacturing environment.
Serve as quality leader on the production line, providing day-to-day oversight & guidance to manufacturing activities.
Utilize knowledge of QSR & ISO 13485.
Act as primary quality contact for production, ensuring production line’s compliance with quality standards.
Review and approve changes made to product and processes, validation/qualification protocols, and reports.
Write reports, data analysis, and business correspondence.
Collaborate with internal customers and suppliers to investigate, document, review, and approve non-conformances, failure analysis reports, and deviations.
Foster effective relationships and integration with other departments and suppliers, collaborating on quality-related activities and initiatives as needed.
Utilize mathematical concepts such as probability and statistical inference to define problems, collect data, establish facts, and draw valid conclusions.
Initiate and update Quality Procedures for Quality Operations functions.
Ensure product compliance with specifications through the implementation of inspection criteria, procedures, and training.
Perform duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements.
Establish and maintain quality metrics to monitor performance and identify areas for improvement.
Identify and lead projects and initiatives aimed at enhancing the quality system and driving continuous improvement across the production line.
Coach and develop junior team members.
Conduct internal audits to assess compliance with quality standards.
QualificationsMust possess a Bachelor’s degree or foreign academic equivalent in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Chemical Engineering, or a related field of study with 5 years of related experience.In the alternative, employer will accept a Master’s degree in aforementioned fields with 1 year of related experience.Each alternative must possess at least 1 year of experience in the following:
working in a quality engineering FDA regulated Medical device manufacturing environment;
writing reports, data analysis, and business correspondence;
utilizing mathematical concepts such as probability and statistical inference to define problems, collect data, establish facts, and draw valid conclusions; &
performing duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements.
Salary Range: $148,408 - $157,500 per yearApply online at https://careers.abbvie.com/en. Refer to Req ID: REF24959K. Additional InformationWe 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 and long-term incentive programs.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.