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Dublin, CA

$48,922 - $59,793

Sr. Quality Engineer

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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 Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. This role is responsible for quality support of New Product Introduction (NPI) and manufacturing. The Quality Engineer will coach manufacturing 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. • 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. • Set up QA best practices for New Product Introduction Validation Activities. • Work with internal customers and Supplier Quality Engineers to ensure that process validation related nonconformances, 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. • Provide guidance (& sign off where necessary) to Manufacturing Change Requests requiring validation. • Provide guidance (& direct input where necessary) to Manufacturing Customer Focus Teams on process validation related activities. • Identify and lead projects and initiatives to improve the quality system. • Coach and develop other team members. • Perform internal audits and other related duties as assigned. • Ability to travel 15% of the time. • Any other responsibilities assigned by manager. Qualifications • Bachelors degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred. • Minimum of 8 years of quality engineering or equivalent 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. • Knowledge of IQ, OQ, PQ’s • Knowledge of Process Validations • Medical Device Auditor certification preferred. • Problem solver. • Self-directed. • Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook. Additional Requirements: • 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 Allergan complies. Language and Verbal Skills: Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally. Math Skills: Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Analytical and Reading Skills: Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. Physical Requirements: The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision. Work Environment: Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate. Safety: Allergan is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Experienced Schedule Full-time Job Level Code M 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.

Job ID: 2063293530976998464