Manager, Manufacturing Quality
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.
This role is responsible for managing quality support for manufacturing of Zeltiq or third party manufactured products. The Manager, Manufacturing Quality will coach manufacturing and quality personnel on GMP and SOP compliance and empower them to identify and escalate quality issues, to ensure overall quality of the product.
Essential Duties and Responsibilities include the following (other duties may be assigned):
- 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
- Work with internal customers and suppliers to ensure that non-conformances, failure analysis reports and deviations are appropriately investigated, documented, reviewed and approved.
- 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.
- Establish and maintain quality metrics.
- Identify and lead projects and initiatives to improve the quality system.
- Coach and develop team members.
- Perform other related duties as assigned.
- Ability to travel 10% of the time.
- Bachelors degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred.
- Minimum of 4-7 years of quality engineering experience in FDA regulated medical device manufacturing environment(s).
- Proficiency in reading and interpreting mechanical drawings and GD&T.
- Knowledge of QSR and ISO 13485.
- Medical Device Auditor certification preferred.
- Problem solver.
- Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
- Knowledge of quality/continuous improvement tools (SPC, Statistics, DOE, Six Sigma) preferred
- Good oral and written communication skills.
- Ability to write reports, data analysis, and business correspondence.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to clearly and concisely convey project accomplishments, obstacles, issues and status to project team members.
- Ability to work with mathematical concepts such as probability and statistical inference.
- Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Ability to use MS Excel to perform calculations and interpret results/data.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to read technical literature and documents and extract important concepts.
- Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.
Significant Work Activities
Yes, 5 % of the Time
Job Level Code
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.